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Job DescriptionRegulatory Affairs Staff SpecialistLocation: San Diego, CA (Onsite) Salary Range: $120,000 - $147,000 Job SummaryBioPhase is seeking a Regulatory Affairs Staff Specialist to support regulatory compliance and product registrations for in vitro diagnostic (IVD) products. This role will lead regulatory submissions, assess product changes, and ensure compliance with FDA, EU IVDR, and global regulatory requirements. The ideal candidate will collaborate cross-functionally to drive regulatory excellence. Responsibilities • Prepare and submit 510(k), IVDR Technical Documentation, and other regulatory submissions., • Conduct regulatory assessments for product changes and compliance., • Collaborate with R&D, Quality, Manufacturing, and Marketing teams., • Monitor global regulatory trends and assess their impact on product compliance., • Review and approve product labeling, advertising, and promotional materials., • Maintain regulatory documentation and support market authorizations., • Bachelor’s degree in Life Sciences, Engineering, or related field (Advanced degree preferred)., • 6+ years in Regulatory Affairs, with 4+ years in IVD Regulatory Affairs., • Experience with 510(k) submissions, IVDR compliance, and global registrations., • Strong knowledge of IVD regulations, ISO 13485, QSR, and international standards., • Excellent written and verbal communication skills for regulatory documentation and agency interactions., • Onsite in San Diego, CA., • Limited travel (<10%).

Job Description Material Handler - Waples Location 2nd shift $19-$20/hr EDUCATION, SKILLS & EXPERIENCE: Education and Experience High school diploma or equivalent preferred Six months of previous work experience in a warehouse/stockroom environment utilizing material handling equipment and computerized inventory control system preferred • Previous experience in a GMP environment preferred, • Trained in the safe usage of basic warehouse equipment such as but not limited to order pickers, preferred, • Basic computer skills including Word, Excel and transaction data entry, • Strong verbal and written communication written skills, • Basic math skills Basic knowledge and understanding of cycle count procedures, • Hands-on experience supplying materials to production work orders, • Strong time management skills, ability to function efficiently with a focus on safe practices, • Demonstrates commitment to complete work in accordance with Quality Management System supporting ISO requirements FDA regulations, and those put forth by other regulatory agencies., • Understands and is aware of the quality consequences and device defects which may occur from the improper performance of their specific job., • Performs manual and clerical duties related to shipping, receiving, storing, issuing, and delivering a variety of materials, equipment, and supplies, • Performs physical counts of inventory, • Transports materials between departments, facilities, and/or production floor, • Transacts inventory/material movements in an accurate and timely manner and in accordance with strong inventory control practices, • Selects and transacts materials for work orders, • Assures the accurate counting, staging and storage of materials and supplies, • Operates warehouse vehicles such sit down, stand up and side-loader forklifts, pallet jacks, and related material handling equipment in narrow aisles and cold storage facilities, • Follows all standard operation procedures and GMP guidelines Company DescriptionMarquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities. Marquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path. Apply with us!Marquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.\r\n\r\nMarquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.\r\nApply with us!

Job Description Position: Senior Scientist, In Vivo - Cell & Gene Therapy Salary Range: $100,000 - $125,000 / yr Location: Carlsbad, CA About Pharmaron Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit . Job Overview: Pharmaron is seeking a Senior Scientist to join our In Vivo team. In this high-impact role, you will lead preclinical studies with a strong emphasis on central nervous system (CNS) models, supporting pharmaceutical and cell and gene therapy programs. You will design, oversee, and interpret in vivo studies while ensuring scientific rigor, regulatory compliance, and effective collaboration across teams. This is an excellent opportunity to contribute to groundbreaking research in CNS and other therapeutic areas, while helping advance innovative therapies through preclinical development. Key Responsibilities • Lead the design, conduct, analysis, and reporting of in-vivo studies, ensuring scientific rigor and regulatory compliance., • Partner with sponsors to develop scientifically sound and cost-effective study designs that meet project needs., • Oversee study scheduling and resource allocation in coordination with in vivo scientists, veterinary staff, and QA/QC teams., • Prepare study protocols and reports, maintaining high standards of accuracy and clarity., • Provide subject matter expertise in animal handling, restraint, dosing, and surgical procedures in rodents and large animals., • Act as a liaison between sponsors and internal teams, fostering transparent communication and timely responses to sponsor requests., • Ensure all study activities adhere to regulatory guidelines (USDA, FDA, AAALAC, OSHA) and IACUC protocols., • Contribute to internal research projects aimed at expanding and optimizing service offerings., • Ph.D. in a relevant scientific field with 3+ years of laboratory animal research experience., • Proven track record in study direction and team leadership within a preclinical or CRO environment., • Strong background in cell and gene therapy programs, with hands-on expertise in animal models and surgical procedures., • Technical expertise in immunology, cell culture, flow cytometry, and experience establishing new laboratory capabilities., • Proficiency in Microsoft Office and statistical analysis software., • Skilled in technical writing of study protocols, reports, and documentation for GLP studies., • Solid foundation in physiology, anatomy, and pharmacology with application in preclinical settings. Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package: • Insurance including Medical, Dental & Vision with significant employer contributions, • Employer-funded Health Reimbursement Account, • Healthcare & Dependent Care Flexible Spending Accounts, • 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance, • 401k plan with generous employer match Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #LI-MC1

Job DescriptionCompany Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. Job Description We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical development of oncology products at ORIC. In this role, you will collaborate closely with colleagues across regulatory operations, quality, CMC, nonclinical and clinical functions to support high-quality, timely regulatory submissions. The ideal candidate is a proactive team player who thrives in cross-functional environments, communicates effectively, and can balance strategic thinking with strong execution. Essential duties and responsibilities include the following. Other duties may be assigned. • Support regulatory submissions and contribute to strategic planning for assigned programs., • Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements., • Responsible for the creation, assembly, review, and archival of complex regulatory submissions which require interaction with internal and CRO teams to ensure optimal execution., • Develop, manage and track regulatory submission timelines., • Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, clinical teams., • Ensure submissions meet standards for accuracy, completeness, and consistency, and maintain health authority correspondence archives., • Review investigator packages and support site start-up activities from regulatory perspective., • Expand knowledge by analyzing current regulatory issues, guidance, initiatives and effectively communicate regulatory intelligence internally., • Bachelor’s degree in a scientific or related field, advanced degree preferred., • At least 4-5 years of regulatory affairs experience in the pharmaceutical or biotechnology industry or a combination of an advanced degree and regulatory experience., • Experience in preparing regulatory submissions (eg, IND, DSUR, CTA, FDA meeting requests)., • Strong communication, interpersonal, and collaboration skills across internal and external stakeholders., • Good project management skills; able to manage multiple projects simultaneously and meet deadlines., • High attention to detail, with excellent problem-solving and analytical thinking abilities., • Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents (eg, investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests)., • A strong scientific background with the ability to quickly acquire knowledge in the therapeutic areas and the evolving regulatory landscape., • Familiarity with global regulatory requirements and guidelines (FDA, ICH), with the ability to gather and analyze latest regulatory intelligence and motivated to learn new things., • Computer expertise, including Microsoft Office Suite proficiency (eg, Word, Excel, PowerPoint). Experience with regulatory information management system (Veeva RIM) is a plus. Additional Information The anticipated salary range for candidates is between $145,000-$165,000 in San Diego. The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristic.

Job DescriptionJob Title: Data Engineer/Senior Data Engineer/Lead Data EngineerLocation: San Diego, San Mateo, Remote FLSA Status: Exempt ClearNote Health is a precision oncology company developing non-invasive diagnostic tests that detect cancer early—when it’s most treatable. We are seeking a Lead Data Engineer to play a pivotal role in shaping and operating the data infrastructure that powers both our scientific discovery and commercial execution. In this high-impact role, you’ll be responsible for architecting and maintaining the data systems that unify our business, clinical, and scientific data into a trusted and accessible platform. You’ll collaborate cross-functionally with R&D, Lab Operations, G&A, Regulatory, and Software Engineering teams to ensure timely, accurate, and secure access to critical data. This is an outstanding opportunity for an experienced data engineer who thrives in a fast-paced environment, enjoys working across diverse domains, and is passionate about using data to transform patient outcomes.Key Responsibilities • Partner with stakeholders across the company to understand their data needs and the systems generating that data., • Design and implement a scalable, sustainable and reliable data operations strategy., • Own the architecture and ongoing evolution of our enterprise data warehouse., • Develop and maintain data contracts between systems of record and the warehouse to ensure data quality and transparency., • Continuously improve the architecture and pipelines for ingesting, transforming, and delivering data., • Create and maintain high-quality documentation for systems, pipelines, and data models., • Collaborate with QA and Regulatory teams to ensure data systems support clinical and regulatory requirements., • Work closely with the R&D team to capture, organize and analyze NGS-based laboratory data from R&D and production environments., • Collaborate with BI team to deliver data from scientific analysis to our business intelligence platform.Qualifications, • Bachelor's degree in Computer Science, Information Systems, Laboratory Science, or a related field; Master’s degree preferred., • 3+ years of experience in data engineering or data operations roles., • Strong proficiency in SQL and Python., • Demonstrated experience with data warehousing and transforming raw data into useful models for business and scientific use., • Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and non-technical teams., • Experience working with scientific data, particularly from next-generation sequencing (NGS), is strongly preferred., • Familiarity with common bioinformatics data formats is a plus., • Bonus: Familiarity with laboratory workflows and relevant regulatory standards (e.g., FDA, CLIA, ISO).What We ValueAt ClearNote Health, we are driven by our mission and guided by our values: • Put Patients First, • Redefining the Possible ClearNote Health is an exciting life science company that is reinventing non-invasive molecular diagnostic testing using next generation epigenomic technologies. We are passionate and dedicated to discovering and developing medicines that will make a significant difference in cancer and other epigenomic-driven diseases. Our technologies provide novel insight and quantitation of human health and disease, with our focus on precision medicine applications improving both clinical and health system outcomes. Our company was founded based on pioneering work in the Stanford laboratory of Stephen Quake, with advisors from Stanford and UCSF. We look for extraordinary lifelong learners with a passion and growth mindset for these areas, and for combining biological ingenuity with AI and data analysis. Led by a team with decades of experience bringing products from concept to market, we are an equal opportunity employer and value diversity at our company. We provide generous benefits to all employees including stock options. We are building a world-class company, based in San Diego and San Mateo. Our commitment to Diversity, Equity, Inclusion, and Belonging: We celebrate diversity in perspectives and backgrounds, and this is reflected in our innovation, our mission, and values. Our differences make us unique, help us innovate, and allow us to persevere. We strive to achieve representation and inclusion and redefine the possible in patients living longer lives. Powered by JazzHR FN9USGaHv0

Job Description The Senior Post Market Surveillance Specialist will play a crucial role in ensuring the safety and compliance of our products in the post-market phase. Supports Regulatory Affairs teams through the creation/maintenance of analytical tools and databases to facilitate Post-Market Surveillance, Regulatory Compliance, Regulatory Submissions, Regulatory Intelligence review and product innovation/improvement activities. Responsible for conducting investigations, analyzing data, and identifying potential risks or regulatory/quality issues related to Argen products. Demonstration of expertise in quality assurance and/or regulatory requirements will contribute to the continuous improvement of our products and processes. Schedule: Monday – Friday: 8:30 am – 5:00 pm Location: 5855 Oberlin Dr, San Diego, CA 92121 The day-to-day: • Develop, implement, and maintain post-market surveillance processes and procedures to ensure compliance with regulatory requirements (e.g.,FDA regulations, EU MDR) and industry standards., • Coordinate and oversee product recall activities, including investigation, risk assessment, communication with relevant stakeholders, and coordination of corrective actions., • Manage global field action activities, including identification, evaluation, and coordination of corrective and preventive actions to address product performance issues and safety concerns., • Ensures timely and accurate Medical Device Reporting (MDR) and adverse event reporting to regulatory authorities as required., • Conducts post-market surveillance activities in compliance with applicable standards and regulations., • Collaborates with cross-functional teams, including but not limited to R&D, Business Development, Quality Assurance, Quality Engineering and Manufacturing, Operations, Supply Chain, Marketing, Sales, Customer Services, and Engineering to gather relevant information for investigations and ensure timely resolution of issues., • Collect, evaluate, and analyze investigation data to identify trends, potential risks, and opportunities for product improvement., • Prepares comprehensive reports on post-market surveillance activities, field actions, reportable events, findings, and recommendations for management review., • Maintains accurate and up-to-date documentation of investigations, including complaint files, investigation reports, and regulatory submissions., • Stays current with relevant global regulatory requirements, industry standards, and best practices related to post-market surveillance, vigilance, field actions, and reportable event, • Participates in internal and external audits and assists in implementing corrective and preventive actions related to post-market activities, as necessary., • Participates in risk management activities, including the evaluation of product risks, identification of hazard mitigation strategies, and implementation of appropriate actions, as necessary., • Bachelor’s degree in Engineering, Science, Law, or other technical field with 4+ years of experience in post-market surveillance, field actions, reportable events, or regulatory intelligence review, or an equivalent combination of education and experience. Advanced degree preferred., • Solid understanding of quality assurance and/or regulatory principles, post-market surveillance activities, and regulatory requirements (e.g. ISO 13485, FDA Regulations)., • Proven experience in global post-market surveillance, field actions, reportable events, regulatory and/or intelligence review roles., • Experience in coordinating and managing product recall activities, including risk assessments, communication plans, and corrective actions., • Proficiency in conducting investigations and root cause analysis of field actions, adverse events, customer complaints, CAPAs, SCARs, public/regulatory database of similar devices, survey collection and analysis, trend reporting, and proactive/reactive feedback., • Strong analytical and problem-solving skills, with the ability to analyze data, identify trends, and develop actionable insights., • Detail-oriented with strong organizational and documentation skills., • Strong analytical skills with the ability to interpret and analyze complex data sets., • Excellent attention to detail and ability to work independently and prioritize tasks effectively., • Familiarity with adverse event reporting systems is preferred., • Knowledge of statistical analysis methods and tools is a plus but not mandatory., • Ability to adapt to changing regulations and industry trends., • Health Plans,Dental Plans, Vision Plan, • PTO, • 401k with Employer Match, • Paid Time Off and Paid Holidays, • Employee Events Argen is a family-owned and privately held company based in San Diego, CA with a state-of-the-art manufacturing center that provides high quality dental solutions to dental labs of all sizes. Founded as a precious metals company in South Africa, Argen has evolved into a dynamic, technology-based manufacturing organization focused on three key business segments, including dental alloys, zirconia, and digital dentistry solutions. Argen continues to invest in innovative product improvement initiatives through its Quality Management System to provide our global customers with affordable, high-performance products and industry-leading excellent service. Argen’s products are FDA regulated and ISO certified.

Job Description Who is CorDx CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Program Director Location: Onsite - Atlanta/San Diego Job Overview: We are seeking a highly skilled and experienced Program Director to lead cross-functional programs within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role will oversee complex product development initiatives from concept through commercialization, ensuring alignment with strategic objectives, regulatory compliance, and time/cost constraints. The ideal candidate will have a strong background in project/program management, deep understanding of the biotech/IVD landscape, and a proven track record in delivering results through collaboration and leadership. Key Responsibilities: • Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch., • Develop and manage detailed program plans, timelines, budgets, and resource allocation., • Serve as the primary point of contact for program status, risk assessment, and issue resolution., • Drive strategic alignment across stakeholders and ensure program goals are met in accordance with company objectives., • Track key milestones and prepare executive-level reporting on program performance and progress., • Facilitate effective communication across internal teams, senior leadership, and external partners., • Ensure programs meet regulatory requirements (e.g., FDA, ISO 13485) and support submission readiness., • Manage program governance, including steering committee meetings and stage gate reviews. Qualifications: • Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree (MS, PhD, or MBA) preferred., • 8-10+ years of experience in the biotech, diagnostics, or medical device industry, with a focus on IVD product development., • 5+ years of program/project management experience in a regulated environment., • Strong knowledge of regulatory pathways, quality systems (e.g., ISO 13485), and clinical development for IVDs., • Proven ability to lead cross-functional teams and manage complex programs with multiple stakeholders., • Life Science/ IVD industry experience preferred., • PMP certification or formal training in project/program management strongly preferred., • Excellent communication, leadership, and organizational skills., • Experience with global product launches and managing distributed teams., • Familiarity with Agile and/or Stage-Gate development methodologies., • Prior experience working with external partners and managing outsourced development/manufacturing., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job Description Job Title: Software Engineer III | Sr. Connectivity Engineer Location: San Diego, CA – 100% onsite – local candidates only Period: 08/26/2024 to 02/28/2025 Hours/Week: 40 hours – hours over 40 will be paid at time and a half Rate: $60 - $70/hour Contract Type: W-2 only, temp to hire potential Scope of Services: The Senior Connectivity Engineer plays a critical role in ensuring seamless connectivity and interoperability between medical devices, cloud platforms, and healthcare systems. This position involves troubleshooting complex integration challenges, implementing standards, and optimizing data exchange. The successful candidate will collaborate with cross-functional teams to enhance product performance and reliability. Role, Responsibilities, and Deliverables: • Integration Troubleshooting:, • Investigate and resolve connectivity issues related to medical devices, cloud services (Azure), and other healthcare systems., • Diagnose and troubleshoot HL7, POCT1A, ASTM, and other relevant protocols., • Address TLS-related challenges to ensure secure data transmission., • Apply comprehensive knowledge of connectivity and device interoperability to the completion of complex assignments, using advanced knowledge of organization’s technologies and practices., • Standards Implementation:, • Implement and adhere to industry standards (HL7, ASTM, etc.) for data exchange., • Ensure compliance with regulatory requirements (FDA, HIPAA, etc.) related to medical device integration., • Cloud Connectivity:, • Collaborate with software development teams to establish robust connections between medical devices and Azure Cloud., • Optimize data flow, latency, and reliability in cloud-based environments., • Linux Expertise:, • Proficiently work with Linux-based systems for device integration., • Troubleshoot Linux-specific issues related to connectivity and data exchange., • Networking:, • Configure and maintain network infrastructure for medical devices., • Address network-related challenges affecting data transmission., • Collaboration:, • Work closely with software engineers, product managers, and quality assurance teams., • Provide technical guidance and mentorship to junior engineers., • Act as Level 3 Connectivity escalation resource to resolve on market customer issues., • Develop and own the device connectivity strategy supporting current products., • Build, and maintain the integration lab to perform integration testing and ensure releases properly interoperate with other devices on the network., • Evaluate current development processes and provide recommendations for improvements., • Understands and is aware of the quality consequences which may occur from the improper performance of the products., • Identify key barriers/core problems and apply problem-solving skills in order to deal creatively with complex situations. Troubleshoot and resolve complex problems, and make decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results., • Work closely with product development team to establish product development goals related to connectivity while ensuring market compatibility., • Use strong technical abilities and able to suggest multiple solutions to problems., • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships, • Carries out duties in compliance with established business policies, • Other duties as assigned, according to the changing needs of the business Experience & Education: • Experience in delivering products for the Medical Device industry., • 10+ years of experience in systems and/or software development involving interoperability of connected devices., • Bachelor of Science, Computer Engineering, Computer Science or equivalent experience (MS preferred). Preferred Qualifications: • Experience with hospital EMR systems such as (Epic or Cerner)., • Experience with healthcare middleware system such as RALS; Telcore and others., • Experience with communications: Wi-Fi, Ethernet, wireless, Bluetooth, TCP/IP, communication stacks., • Experience testing communication interfaces between devices on both wired and wireless networks., • Experience with testing of healthcare communication protocols (e.g. ASTM, HL7, POCT1A, ADT, FHIR)., • Experience with Integration Frameworks such as (Mulesoft, Apache Camel or equivalent)., • Experience with network protocols, integration and integration testing, and cybersecurity, • Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, FDA SW Guidelines…)., • Master of Science, Computer Engineering, Computer Science or equivalent experience., • Experience in delivering products for the Medical Device IVD industry., • Experience with testing techniques for cloud solutions., • Strong written, verbal, interpersonal and presentation skills., • Good understanding of the TLS\HTTPS REST\SOAP protocols., • Good understanding of OAuth 2.0\Open ID Connect protocols.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Manager of Safety Operations will be responsible for the flawless execution of Safety and Pharmacovigilance operations. They will be responsible for maintaining Arrowhead's safety database, preparation and review of regulatory reports such as serious unexpected serious adverse reactions (SUSARs) and periodic aggregate reports in compliance with FDA, EMA and other international guidelines and regulations for the clinical programs. The manager will interface and collaborate with Clinical Operations, Quality Assurance, and Regulatory team members and provide safety support during the set-up of new clinical development programs as well as assist in the oversight of local CRO vendors who perform local safety reporting for Arrowhead. Responsibilities • Lead activities related to implementing and maintaining the Safety Database, supporting ARGUS activities, Overseeing the Safety Vendors, and coordinating the Safety Reporting from Clinical Trials and Collaborators., • Support and/or Lead Safety Operations and ensure flawless execution of Safety and Pharmacovigilance processes, • Vendor management, manage Safety Vendors, CRO and other external parties helping Arrowhead's drug Safety and Pharmacovigilance., • Provide drug safety case management support to medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data, • Lead reviewing and monitoring of SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety, • Supervise the development and updating of Clinical Risk Management Plans for all clinical Prepare and update study-specific Safety Monitoring Plans as needed, • Oversee compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies, • Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure the reconciliation process is occurring for all clinical studies, • Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety support, • Support the Head of Safety in the review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event {SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations), • Supervise managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results, • Oversee monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements, • Support in quality assurance activities, including deviation reports and generating necessary CAPA to ensure Arrowhead is meeting all safety compliance requirements, • Manage Arrowhead's QMS for safety/Pharmacovigilance procedures, • Minimum of BS/BA degree in a health-related area, • 5 years in the pharmaceutical industry or CRO with at least 3 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience, • Strong working knowledge of FDA and international adverse event reporting regulations (ICH, EMA GPV, GCP etc.) and the ability to interpret and apply applicable regulations, • Strong working knowledge of case management and Experience in using ARGUS or other safety databases. Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medications, • Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs), • Experience with quality assurance and compliance for drug safety, • Experience with regulatory inspections, as well as audits of service vendors/business partners would be helpful, • Good organizational skills with the ability to perform multiple tasks efficiently and effectively while mentoring and leading team members, • Proficiency in standard desktop software programs (Word, Excel, Outlook), • Competency in obtaining, analyzing, and reporting safety data, • Strong oral and written communication skills, • Motivated self-starter who can lead teams and work independently, • Strong interpersonal skills with the ability to professionally interact with all levels of personnel California pay range $115,000—$145,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines, and develop and execute regulatory plans. This position will report to the Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions. Responsibilities • Lead the preparation and submission of regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.), • Participate or lead the preparation for Health Authority interactions, • Collaborate with the global regulatory lead and regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications., • Work with global regulatory lead to create and maintain submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions., • Work with regulatory leads to monitor timelines and key program activities and tracking submission deliverables to maintain target submission dates., • Assess and communicate regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines, • Ensure timely and accurate communications of regulatory updates and decisions to internal stakeholders., • Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams, • Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals, • Research and analyze regulatory information and maintain current regulatory knowledge, • Ensures day-to-day regulatory requirements are met for their assigned programs and manager (i.e., archiving, submissions), • Education equivalent to a BS or MS, plus 5 years of hands-on regulatory experience, or, • Education equivalent to a higher degree (PharmD or PhD), plus 3 years of hands-on regulatory experience,, • Experience with international regulatory submissions., • Experience using Veeva RIM and SmartSheets, • Knowledgeable in ICH and FDA guidelines relevant to clinical aspects of product development., • Ability to manage complex projects and timelines in a collaborative matrix team environment., • Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills., • Ability to manage and execute on multiple projects ranging from complex to highly detailed administrative tasks, • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors., • Demonstrated ability to excel in smaller entrepreneurial organizations., • Writing de-novo regulatory documents (eg, Cover letters, meeting requests, briefing books etc.), • Experience in review of ICFs, Phase 1-4 clinical protocols, IBs, etc. to ensure they meet regulatory requirements and agreements Preferred: • Experience in submission of CTAs globally (i.e. EU, UK, Canada, New Zealand, Australia, Taiwan), • Filing experience (new IND, and/or BLA/NDA original / efficacy supplements), • Maintenance of INDs, CTAs, BLA/NDAs All applicants must have authorization to work in the US for a company. 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Job DescriptionRegulatory Affairs ManagerLocation: San Diego, CA (Onsite) Salary Range: $145,000 - $165,000Job SummaryBioPhase is seeking a Regulatory Affairs Manager to lead regulatory strategy and compliance for in vitro diagnostic (IVD) products. This role oversees regulatory submissions, market authorizations, and agency communications, ensuring compliance with FDA, EU IVDR, and global regulations. The ideal candidate will collaborate cross-functionally and drive regulatory excellence.Responsibilities • Develop and execute global regulatory strategies for IVD products., • Lead preparation of 510(k), IVDR Technical Documentation, and other regulatory submissions., • Manage regulatory assessments for product changes and compliance., • Collaborate with R&D, Quality, Manufacturing, and Marketing teams., • Mentor and lead a team of regulatory professionals., • Monitor global regulatory trends and implement best practices., • Support regulatory inspections and audits.Qualifications, • Bachelor’s degree in Bioengineering, Biochemistry, Molecular Biology, or related field (Advanced degree preferred)., • 8+ years in Regulatory Affairs, with 5+ years in IVD regulatory roles., • Experience securing approvals in US, EU IVDR, Canada, Australia, etc., • Strong leadership and cross-functional collaboration skills., • Proficiency in regulatory submission tools and Microsoft Office Suite.Work Environment & Travel, • Onsite in San Diego, CA., • Limited travel (<10%).

Job Description COMPANY DESCRIPTION: Syner-G BioPharma Group is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market. We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality. Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide. Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) • Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification., • Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR)., • Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures., • Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities., • Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments., • Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes., • Support the resolution of regulatory observations or manufacturing site issues. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education: • 4-7 years of experience within the biotech, pharmaceutical, or medical device industry., • Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required., • Validation expertise in Equipment, CSV, Method, and Process., • Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $88,000 to $104,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Regulatory Affairs Manager Location: Onsite - San Diego, CA Position Summary: The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances. Key Responsibilities: • Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies., • Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards., • Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements., • Stay current on changes in regulatory requirements and assist in assessing the impact on company processes and products., • Perform regulatory assessments for product changes and propose appropriate regulatory pathways., • Maintain documentation and records of all regulatory submissions and correspondence., • Support the preparation for regulatory agency meetings, audits, and inspections. Education: • Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required., • 5–7 years of regulatory affairs experience within the medical device or IVD industry., • Working knowledge of 510(k) submissions and regulatory documentation processes., • Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements., • Strong organizational and project management skills with the ability to manage multiple projects and priorities., • Excellent communication, problem-solving, and attention to detail., • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Supply Chain Manager Location: Onsite - Atlanta, or San Diego Salary Range: $80,000 - $120,000 Job Overview The Supply Chain Manager oversees supply chain and logistics operations to ensure efficiency, productivity, and compliance within the pharmaceutical manufacturing industry. This role involves developing strategies, monitoring performance, and implementing policies to optimize processes, reduce costs, and align supply chain activities with company objectives and regulatory standards. Key Responsibilities • Strategic Planning: Design and implement supply chain strategies to meet company goals, forecast demand, and adapt to market changes., • Operations Management: Oversee procurement, production, warehousing, and distribution, ensuring seamless operations and optimized workflows., • Vendor Relations: Manage supplier relationships, negotiate contracts, and evaluate performance for quality and cost-effectiveness., • Inventory & Demand: Maintain optimal inventory levels, implement control techniques, and align production with customer trends., • Logistics: Coordinate transportation and work with third-party logistics (3PL) providers to ensure timely deliveries., • Cost Management: Monitor costs, create budgets, and implement savings strategies while maintaining quality standards., • Data Analysis: Analyze supply chain performance metrics and recommend process improvements., • Risk Management: Identify risks, ensure regulatory compliance, and enforce health and safety policies. Education & Experience: • Bachelor’s degree in Supply Chain, Logistics, Business, or related field., • Strong knowledge of supply chain processes, logistics, compliance, and quality assurance., • Proficiency in ERP and supply chain software (e.g., SAP, Oracle)., • Excellent organizational, project management, and leadership abilities., • Advanced Education & Certifications: Master’s degree or certifications such as CPIM, CSCP, or CLTD., • Industry & Regulatory Knowledge: Familiarity with FDA, GMP, and ISO 13485 regulations. Experience in global logistics and applying lean supply chain principles., • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job DescriptionDescription: REPORTS TO Chief Operating Officer JOB DESCRIPTION/SUMMARY The Senior Manager, Regulatory Affairs will manage, evaluate, and complete regulatory projects consistent with company goals. This position is responsible for primary authorship and supporting CMC regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements maintaining the electronic trial master files, reviewing, and overseeing the production of clinical and regulatory documents in support of product development applications. ESSENTIAL DUTIES AND RESPONSIBILITIES The main Regulatory Affairs responsibilities of this role include but are not limited to the following: • Serves as the regulatory lead on CMC development teams, providing guidance and oversight., • Manages administrative aspects of global regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of the highest quality, and delivered on-time., • Represents Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, and IMPD filings., • Develops, reviews and/or files INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring and managing the development of DSURs, annual reports, CSRs, Protocols, Investigator Brochures, and amendments as needed., • Provides regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs., • Conducts regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams., • Collaborates with and supervises contributions from contractors and vendors., • Develops and manages project timelines for regulatory submissions., • Manages and maintains the electronic trial master files for regulatory, clinical, and non-clinical departments., • Bachelor's degree in scientific discipline with at least 5 years of experience in CMC Regulatory Affairs., • Proven success in preparing and submitting CMC sections of INDs, CTAs, NDAs, and MAAs, • Deep understanding of global regulatory frameworks and evolving guidelines, • Ability to lead in a fast-paced, collaborative environment with shifting priorities, • Strategic mindset with a hands-on approach to problem-solving and execution, • Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical) including experience with CTD/eCTD., • Working knowledge of GMP, GLP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle., • Working knowledge of FDA and ICH regulatory guidance and regulations., • High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom, • High attention to detail and excellent proofreading and editing skills, • Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion, • Ability to multi-task, professional demeanor, strong attention to detail, • Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude, • Must be dependable; someone willing to go the extra-mile to get things done Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Job DescriptionSalary: 160,000 - 210,000 About Codera Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. Position Summary The Site Director, Clinical Operations is responsible for overall clinical site management, including site identification, feasibility, pre-study site evaluation, study start-up, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of Coderas clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. Using available systems and tools, the Site Director, Clinical Operations will monitor and oversee site activities both onsite and remotely to ensure that patients rights, safety and well-being are protected and that the data generated at sites are complete and accurate. The Site Director, Clinical Operations will be accountable for patient enrollment and overall delivery of high-quality patient data in established timelines for all designated sites and/or assigned region. Essential Duties and Responsibilities Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines Develop and cultivate strong site relationships and ensure continuity of site relationships Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance Identify, assess, escalate and resolve site performance or quality issues in a timely manner Complete feasibility and site identification activities for new clinical studies Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments) Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance Responsible for the development of site specific recruitment, retention and follow-up plans Facilitate and support investigator site audits and/or inspection activities as needed Perform remote data review and query resolution for designated sites Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives Coach and mentor colleagues as needed Contribute to the review of Coderas systems and procedures as needed May be involved, when needed, in other areas of study management and staff training Execute other duties as assigned Qualifications Bachelors Degree in a Life Science discipline required Bachelors Degree in Nursing or RN a plus Minimum 3 years of direct site monitoring experience required Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required Thorough understanding of FDA, ICH and GCP guidelines and applicable local regulations Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle Detail-oriented, organized and committed to quality and consistency Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines Excellent team-interaction skills and ability to work successfully in team settings Ability to work in a dynamic environment with a high degree of flexibility Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs Excellent written and verbal communication skills Experience and proven proficiency in CTMS and eTMF systems preferred Must be willing and able to travel up to 50-65% While relocation is not required, the successful candidate must be able to travel frequently (5065%) to sites located in Washington (WA), Oregon (OR), California (CA), and Arizona (AZ). Proximity to a major airport and flexibility for multi-day travel are essential. remote work

Job DescriptionCompany Description CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution. Job Description We are seeking a skilled and experienced Process Engineer III/ IV with deep expertise in small molecule manufacturing to join our engineering consulting team. This role combines technical leadership with strategic client engagement, supporting process design, scale-up, optimization, and regulatory compliance across a variety of pharmaceutical and chemical industry projects. The Process Engineer III will lead the design and execution of process scopes—such as unit operations, systems, or facility areas—on small to medium-sized projects. You will manage scope, budget, and schedule, while maintaining clear communication with clients and internal teams. This role also includes mentoring junior staff, contributing to high-quality deliverables, and supporting capital project planning and regulatory alignment. This position can be based near any CRB location Key Responsibilities • Lead and support client projects focused on small molecule API process development, scale-up, and manufacturing optimization., • Conduct site assessments, gap analyses, and provide recommendations for process improvements and compliance., • Develop process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and mass/energy balances., • Translate client requirements into actionable design scope and document decisions, open issues, and action items., • Identify and escalate scope changes or design deviations to project leadership., • Collaborate with cross-functional teams including architecture, mechanical, electrical, and construction., • Prepare technical reports, proposals, and presentations for internal and client stakeholders., • Support capital project planning including feasibility studies, equipment selection, and facility design., • Ensure alignment with industry standards including cGMP, FDA, EMA, and ICH guidelines., • Participate in advanced project activities such as:, • Technical bid tabulations, • Vendor package management, • Factory acceptance testing, • Risk assessments (e.g., HAZOP, HACCP), • 3D model reviews and coordination, • Sequence of operations and functional specification reviews, • Mentor junior engineers and design staff., • Lead system design programming and planning with support from senior engineers., • Participate in cross-discipline squad checks and drive overall project quality.Qualifications Minimum Qualifications • Bachelor’s or Master’s degree in Chemical Engineering or a related discipline (ABET-accredited)., • Minimum of 5 years of experience in small molecule process engineering, preferably in a consulting or client-facing role., • Strong understanding of chemical synthesis, purification, and formulation processes., • Experience in design firm or operating company settings within a related industry., • Strong written and verbal communication skills., • Intermediate experience with applicable industry and regulatory guidance and building codes., • Advanced technical knowledge and experience with small molecule API manufacturing equipment and utility systems, such as chemical reactors, filters, centrifuges, dryers, vacuum pumps, scrubbers, purified water, process compressed gases, and engineered heat transfer fluid systems., • Experience designing and implementing engineering controls for containment of highly potent APIs., • EIT or PE certification., • Experience coordinating and managing design within project teams and with external partners., • Familiarity with commissioning, startup, qualification, and troubleshooting of process systems., • Experience with regulatory environments and validation documentation., • Prior experience in engineering consulting or client services., • Familiarity with process safety, risk assessments, and HAZOP studies. Additional Information All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening. CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails. CRB offers a complete and competitive benefit package designed to meet individual and family needs. If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Document Control Specialist Location: Hybrid - San Diego Salary Range: $70,000 - $75,000 Position Summary: The Document Control Specialist is responsible for managing the flow and storage of all controlled documents within the organization. This role ensures that documents are accurate, up-to-date, and available to all employees who require them. The specialist will maintain the Master Control document management system, ensure compliance with regulatory requirements, and support continuous improvement initiatives related to document control. Key Responsibilities: • Document Management:, • Manage the creation, revision, distribution, and archiving of controlled documents, including SOPs, work instructions, forms, and other quality-related documentation., • Ensure that all documents are properly labeled, indexed, and stored in the document management system (Master Control)., • Coordinate document review and approval processes, ensuring timely updates and compliance with internal procedures., • Compliance and Quality Assurance:, • Ensure that all controlled documents comply with relevant regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820) and company policies., • Participate in internal and external audits, providing document control support and ensuring that documentation is readily available for inspection., • Assist in the development and maintenance of document control procedures, templates, and guidelines., • System Administration:, • Maintain and administer the Master Control electronic document management system, ensuring user access is controlled and that the system is functioning effectively., • Train staff on document control procedures and the use of the document management system., • Monitor and track document changes, ensuring that version control is maintained and that obsolete documents are removed from circulation., • Continuous Improvement:, • Identify opportunities for process improvements in the document control function and contribute to the implementation of best practices., • Collaborate with other departments to streamline document workflows and enhance efficiency., • Support the development and implementation of document control metrics to monitor system performance and compliance., • Communication and Support:, • Act as the primary point of contact for document control inquiries, providing guidance and support to staff., • Education:, • Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Business Administration) or equivalent experience., • Experience:, • 2+ years of experience in document control, quality assurance, or a related role within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology)., • Familiarity with document management systems and quality management systems., • Hands on experience with Master Control., • Skills:, • Strong attention to detail and organizational skills., • Excellent written and verbal communication skills., • Ability to manage multiple tasks and prioritize effectively in a fast-paced environment., • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and document management software., • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

Job Description We are looking for an experienced Quality Manager to ensure that our products and services meet all necessary requirements before they reach the consumer. The Quality Manager, or Quality Assurance Manager, will inspect the final product to make sure it has been built with compliance to legal standards and meets customer expectations. A great quality manager is thorough and observant with an eye for detail. They must fully understand the requirements for the product or service and have a sense of responsibility towards our potential and existing customers as well as the competition. The goal is to help preserve our reputation by ensuring that our products and services are capable to drive sustainable growth. Position: Quality Manager Location: San Diego(Onsite) Salary: $100,000- $130,000 Responsibilities • Understand customer needs and requirements to develop effective quality control processes, • Devise and review specifications for products or processes, • Set requirements for raw material or intermediate products for suppliers and monitor their compliance, • Ensure adherence to health and safety guidelines as well as legal obligations, • Supervise inspectors, technicians and other staff and provide guidance and feedback, • Oversee all product development procedures to identify deviations from quality standards, • Inspect final output and compare properties to requirements, • Approve the right products or reject defectives, • Keep accurate documentation and perform statistical analysis, • Solicit feedback from customers to assess whether their requirements are met, • Submit detailed reports to appropriate executives, • Implement, manage, and improve the company’s quality management system, with a primary focus on IVD products and equipment., • Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA)., • Lead and participate in internal audits and management reviews of the company's quality system as a key member of the quality department., • Manage the documentation of the company’s quality management system, ensuring compliance with relevant standards and regulations., • Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards., • Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed., • Update company documents in accordance with new or revised quality standards, laws, and regulations., • Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements. Requirements • Minimum Bachelor’s degree in Science or related field., • ISO 13485:2016 lead auditor certification preferred., • Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards., • Strong understanding of quality management principles and practices in the medical device industry., • Excellent communication and interpersonal skills., • Ability to work collaboratively in a team environment., • Demonstrated problem-solving and analytical skills., • Attention to detail and strong organizational skills., • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service

Job Description PURPOSE Operate the automated plasmapheresis machines, monitor donors, and ensure that donors experience a safe and successful plasmapheresis procedure. General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards. ESSENTIAL RESPONSIBILITIES & DUTIES • Set up and operate instruments used for donor qualification and donation;, • Perform all necessary steps for successfully harvesting Source Plasma., • Perform arm scrub in accordance with SOP., • Perform phlebotomy., • Assist in determining donor vein suitability., • Monitor donors and equipment operation to ensure health of donor and quality of product., • Ensure and maintain accurate and thorough documentation of necessary records as required by SOPs., • Build rapport with donors to ensure overall customer satisfaction with center and encourage return visits., • Ensure accurate and thorough documentation in NexLynk and necessary records as required by SOP., • Prepare bleach solutions and other disinfectant solutions as required., • Clean and perform daily, weekly and monthly maintenance of PCS2., • Ensure proper cleaning of equipment and supplies to prevent cross contamination., • Clean beds, carts and/or other equipment on donor floor., • Log and stock incoming supplies as needed., • Ensure donor confidentiality is maintained., • Maintain instruments used for donor qualification and donation;, • Document operational and maintenance activities;, • Assess supply inventory; order and restock, as needed;, • Attend to donor’s needs, including donor reactions., • Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated., • Any other duties as assigned. REQUIREMENTS • High school diploma or equivalent (Must be able to show proof), • Phlebotomy certification from an accredited institution is preferred, • Strong customer service skills., • Must be proficient in English (Read, Write, Speak) with legible handwriting, • Current CPR card, • Proficient with computer entry, • May be required to travel for training, • Bilingual (English/Spanish) PHYSICAL DEMANDS Performing the responsibilities of the job requires ability to talk and hear. Regularly required to use hands and fingers, to handle & feel objects, tools and controls; reach with hands and arms. Vision abilities required by this job include close vision. Required to stand for extended intervals, walk, climb and balance; stoop, kneel and crouch. Physical ability to operate equipment used on donor floor areas that may require repetitive motion and manual dexterity. Ability to lift, tug, and pull up to 50 pounds. Ability to read while standing or sitting in front of a computer for short periods of time. WORK ENVIRONMENT This job routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Occupational exposure to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as eyewear, lab coats, and gloves.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Summary: CorDx Inc. is seeking a highly skilled and experienced Director of Regulatory Affairs to lead 510(k) submissions for our IVD products. This role is responsible for overseeing regulatory strategies, FDA interactions, and compliance efforts to ensure the successful and timely market clearance of new and existing products. The ideal candidate will possess in-depth knowledge of the 510(k) submission process, regulatory risk assessment, and cross-functional collaboration to support business objectives. Key Responsibilities: • Lead and manage the entire 510(k) submission process, including preparation, compilation, review, and submission to the FDA for IVD products., • Oversee all aspects of regulatory submissions, including Traditional, Special, and Abbreviated 510(k)s, ensuring completeness and compliance with 21 CFR 807 and FDA guidance., • Develop and execute regulatory strategies to achieve successful 510(k) clearance in alignment with business timelines., • Conduct regulatory gap assessments to determine appropriate pathways and data requirements for submission., • Ensure regulatory submissions contain all required elements, including:, • Device Description & Intended Use, • Predicate Device Comparisons, • Performance Testing (Analytical & Clinical Data), • Risk Management Documentation, • Software & Cybersecurity Documentation (if applicable), • Labeling & IFU Compliance, • Maintain proactive communication with the FDA, including responding to Requests for Additional Information (AI Letters) and leading pre-submission (Q-Sub) meetings as needed., • Work closely with R&D, Quality, Clinical, and Manufacturing teams to gather and validate technical and performance data for regulatory submissions., • Conduct regulatory risk assessments and implement mitigation strategies to ensure compliance with evolving FDA regulations., • Stay updated on regulatory changes, new FDA guidance documents, and enforcement trends to adapt submission strategies accordingly., • Oversee post-market regulatory compliance, including device modifications, change assessments, and follow-up regulatory filings., • Review and approve labeling, promotional materials, and product claims to ensure compliance with FDA and global regulatory requirements., • Mentor and train regulatory team members on 510(k) submission best practices and regulatory compliance. Base Pay Range $100000-$200000/Yearly Package include: Base Pay+Job skills+Bonus+Commission Requirements ·Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field. Minimum of 8-10 years of experience in IVD or medical device regulatory affairs, with a strong focus on 510(k) submissions. Extensive knowledge of FDA 510(k) submission requirements, pre-submission meetings (Q-Sub), and post-market requirements. Proven experience in preparing and submitting successful 510(k) applications and responding to FDA inquiries (AI Letters, Interactive Reviews, etc.). Strong understanding of regulatory frameworks, including 21 CFR Part 807, ISO 13485, IVDR, and CLIA requirements. Experience leading interactions with the FDA, including regulatory negotiations and Q-Sub meetings. Excellent project management skills, with the ability to oversee multiple regulatory submissions simultaneously. Strong technical writing skills, with the ability to compile complex scientific and regulatory data into clear, concise submissions. Ability to work cross-functionally with internal teams and external regulatory bodies. Preferred Skills RAC certification or similar. Benefits • Health Care Plan (Medical), • 401K, • Paid Time Off and Paid Sick Leave

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Regulatory & Compliance Specialist Location: Onsite - San Diego Salary Range: $90,000 - $95,000 Position Summary: The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. This role will work closely with cross-functional teams to support product development, manufacturing, and post-market activities. The specialist will ensure that all documentation and files related to diagnostic development are completed in a timely manner and are ready for inspections. Key Responsibilities: • Ensure compliance with regulatory requirements for In Vitro Diagnostic products, FDA 21 CFR Part 820, ISO 13485., • Provide regulatory guidance during the product development process, ensuring that products are designed and developed in compliance with applicable regulations., • Participate in risk management activities, including the development and maintenance of risk management files according to ISO 14971 and FDA 21 CFR Part 820., • Conduct risk assessments and work with product development teams to mitigate identified risks., • Participate in design reviews meetings and validation activities, ensuring that regulatory and quality requirements are met., • Review and approve design control documentation, including design input and output, design verification and validation protocols, ensuring that all documentation meets regulatory requirements., • Review and approve design history file for each new product., • Education:, • Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs, Quality Management) or equivalent experience., • Advanced degree or certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., CQE, CQA) is a plus., • Experience:, • 3+ years of experience in regulatory affairs, quality assurance, or compliance within the medical device or In Vitro Diagnostics industry., • Experience with regulatory submissions, including 510(k) and CE marking, is highly preferred., • Strong knowledge of global regulatory standards, including FDA regulations and ISO 13485., • Skills:, • Strong understanding of IVD product development and manufacturing processes., • Excellent written and verbal communication skills, • Strong analytical and problem-solving skills, with attention to detail and accuracy., • Ability to work independently and as part of a team, with strong organizational and time-management skills., • High level of integrity and commitment to upholding regulatory and quality standards., • Proactive approach to identifying and addressing compliance risks and issues. Benefits • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Associate Regulatory Affairs Manager Location: Onsite - San Diego, CA Position Summary: The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulatory projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle. Key Responsibilities: • Assist in the preparation, review, and submission of regulatory documentation for new products, product changes, and ongoing compliance., • Support the regulatory submission process for 510(k), Technical Files, and other regulatory filings., • Provide regulatory guidance to cross-functional teams during product development and post-market activities under the direction of senior management., • Help track and manage submission timelines, regulatory project plans, and documentation., • Stay informed on changes in FDA, ISO 13485, IVDR, and other global regulations, communicating relevant updates to the team., • Conduct regulatory assessments for product modifications and assist in defining appropriate submission strategies., • Participate in internal and external audits, inspections, and regulatory agency communications as assigned., • Contribute to the maintenance of regulatory files and submission records in accordance with internal procedures and regulations. Education: • Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field., • 4–6 years of regulatory affairs experience in the medical device or IVD industry., • Experience supporting or managing 510(k) submissions and regulatory filings., • Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and international medical device regulations., • Strong organizational, document management, and project coordination skills., • Excellent communication, problem-solving, and cross-functional collaboration abilities., • Detail-oriented with the ability to manage multiple regulatory projects and priorities., • Proficient in Microsoft Office and regulatory document management systems., • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job Description About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit . Job summary The Senior Quality Engineer is an onsite position and very hands-on with Quality System elements such as NCMR’s, CAPA’s, Batch (DHR) release, change orders, drawing review, quality inspection records, and product disposition. The Senior Quality Engineer is responsible for developing, maintaining and analyzing supplier quality systems and procedures to ensure compliance with FDA regulations, corporate directives, ISO 13485 standards and company strategies. This position is also responsible for Quality input, technical support, conducting investigations, and providing guidance for Manufacturing, Engineering, and Regulatory Affairs, especially as related to product and components from suppliers. This position is responsible for performing investigations and inspections as necessary and identifying and implementing quality assurance testing models for analysis of raw materials, materials in process, and finished products. The Senior Quality Engineer assists in developing quality control policies and evaluates production challenges and determines improvement opportunities. Essential job functions and duties • Lead and conduct on-site supplier qualifying and monitoring audits representing Inovio in a professional manner to ensure compliance with company requirements and expectations, including appropriate regulations & standards (e.g., FDA’s 21 CFR 820, ISO 13485 & ISO 9001, etc.), • Leads root cause analysis of defects to identify and drive corrective actions. Ownership of QMS elements such as CAPA’s, NCMR’s, Complaints etc., • Develop, author, and implement quality assurance protocols for mechanical systems, components and product testing., • Perform GD & T evaluations on tolerance stack ups., • Conduct component validations at suppliers and internally, including writing comprehensive protocols and reports based on statistical analysis., • Present supplier performance metrics, including defect rates, trending data, and quality throughput., • Lead and collaborate with suppliers in a timely manner to address quality issues and non-conformances, driving implementation of process improvements through SCAR’s., • Maintain an updated supplier performance database, • Oversee product, component, assembly and process qualifications at suppliers., • Report discrepancies and positive/negative trends to management to drive process improvements., • Participate in the review of engineering specifications to ensure that adequate requirements are met., • Review drawings for adherence to design inputs; material callouts and standards and procedures; and regulatory and QS requirements; verify that required reports are attached so that the project can proceed to the next phase., • Support QMS systems and organizational growth, including participation in MRB meetings, Batch reviews, product release, and CAPA investigations., • Prepare and present detailed reports on quality metrics, supplier performance, and corrective actions., • Bachelor’s degree in Mechanical Engineering, Engineering, Quality Management or a related field, or equivalent related experience., • Minimum 10 years of experience with software driven electronic medical devices., • In depth experience in Quality within a medical device manufacturing environment with expertise in cGMP, QSR, ISO, MDD, and MDR regulations., • Minimum 3 years of experience in supplier audits and supplier qualification implementation., • Certifications such as Six Sigma Green/Black Belt or ASQ Certified Quality Engineer (CQE) a huge plus., • Strong knowledge of ISO 13485, FDA QSR Part 820, and EU MDR., • Experience with alternative Quality related tools (D and P, FMEA, QFD, SPC, Risk Analysis, DOE, and TQM) also a plus. Proficiency in Microsoft Word, Excel and Outlook, Visio, PowerPoint Visual Basic, Access, and Mini-Tab or other comparable statistical analysis software application., • Familiar with investigational tools such as 5-Whys, Fishbone Diagrams, Turtle Diagrams, etc., • Detail-oriented and organized in meetings and reviews., • Strong understanding of statistical methods., • Strong ability to write reports, business correspondence, and procedure manuals., • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form., • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists., • Proven project management skills; able to complete technical projects on time and with limited supervision., • Have organizational, communication skills and the ability to perform varied tasks in a disciplined, consistent manner., • Ability to work individually or within a Team in a fast-paced and team environment., • Experience with sterilization validation (gamma/EO), design controls, and statistical analysis, • Familiarity with Class II/III medical devices INOVIO Pharmaceuticals, Inc. is an Equal Employment Opportunity Employer, including but not limited to veterans and individuals with disabilities. We prohibit discrimination of any kind. In keeping with our policy, we recruit, hire, train, and promote the most qualified individuals for all job titles, and we provide equal opportunities to all employees and applicants for employment. A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer. Important notice to employment businesses/agencies INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Director/ Director, Drug Safety will be responsible for maintaining Arrowhead's safety database, preparation and review of regulatory reports such as serious unexpected serious adverse reactions (SUSARs) and periodic aggregate reports in compliance with FDA, EMA and other international guidelines and regulations for the clinical programs Responsibilities • Lead Case Processing and support safety medical review, generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed and work with CRO to determine when cases are complete and ready to close., • Ensure consistency in investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility., • Participate in the standardized set-up of new safety projects, including development of Safety plans and documents, and set-up of safety systems, • Prepare, support and track PVAs/SDEAs with partners., • Monitor compliance with partner Safety related activities needed as per PVA/SDEA., • Create and maintain Safety Management Plans and Reporting documents in collaboration with vendors., • Review vendor scope and assist with study level budgets as needed., • Provide vendor oversight, including tracking KPI's and collaborate with multiple vendors for process setup & improvements., • Perform and manage SAE reconciliation between databases., • Responsible for data clean-up and data migration from vendor Safety database., • Oversee submission activities for ICSRs and aggregate reports., • Collaborate with vendors for TMF Safety documents filing and review., • Manage day to day operation of Safety database., • Ensure that reported SAE (and events of special interest to include pregnancy and overdose) event reports are received, tracked, evaluated, processed and distributed/submitted in an efficient and timely manner, and in compliance with regulations and Arrowhead Management Plans/SOPs., • Coordinate with vendors to ensure all internal/external timelines are met per PVA and ensure, potential issues are communicated, and resolution is achieved in a timely manner., • Support activities related to implementing and maintaining the Safety Database, supporting ARGUS activities, Overseeing the Safety Vendors, and coordinating the Safety Reporting from Clinical Trials and Collaborators., • Support other members of Safety Operations and Science personnel and ensure flawless execution of Safety and Pharmacovigilance processes, • Vendor management, manage Safety Vendors, CRO and other external parties helping Arrowhead's drug Safety and Pharmacovigilance., • Facilitate the analysis of similar events for expedited safety reports occurring in pre-marketed clinical studies., • Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations., • Provide drug safety case management support to Safety medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data., • Assist with the development and maintenance of departmental SOPs and other procedural documents., • Support reviewing and monitoring of SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety, • Support the development and updating of Clinical Risk Management Plans for all clinical Prepare and update study-specific Safety Monitoring Plans as needed, • Help in compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies, • Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure the reconciliation process is occurring for all clinical studies, • Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety, • Participate in inspection-readiness activities to included document and eTMF support., • Collaborate with Regulatory personal and CROs to communicate upcoming SAEs requiring expedited submissions to Regulatory Authorities, to include ad hoc reporting responsibilities form Arrowhead Safety., • Support the Manager of Safety Operations and Head of Clinical Safety in the review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event {SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations), • Informs Manager of safety related issues and potential trends and or signals arising from review of post-marketed safety data., • Assist with safety database test configurations., • Assist with review of cross-functional documents/plans (e.g., protocols, SAE Reconciliation Plans, etc.), • Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations., • Help in managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results, • Support monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements, • Maintenance of Arrowhead safety operations documentation (e.g., safety case files), and management of the Safety Mailboxes., • Help in quality assurance activities, including deviation reports and generating necessary CAPA to ensure Arrowhead is meeting all safety compliance requirements, • Participate in the production and validation of appropriate safety data output from the external or internal safety database for required safety deliverables (e.g. DSUR, IB, ad hoc analyses etc.)., • Manage Arrowhead's QMS for safety/Pharmacovigilance procedures, • Participate in and Help with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities, • Responsible for UAT and Implementation of updates within Safety Database., • Responsible for Argus console activities like maintaining user sites, groups, accounts, workflow, product, study configurations, and reporting rules., • Perform periodic MedDRA and WHO Drug upgrades., • Assist with periodic Disaster recovery and Business continuity tests as needed with Safety Database., • Support Drug Safety team with listings and data from the Argus database., • Minimum of BS/BA degree in a health-related area (RN/BSN) and 8 years in the pharmaceutical industry or CRO, • 5-10 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience, • Prior experience in Safety/Pharmacovigilance Operations is required., • Strong working knowledge of case management and Experience in using ARGUS or other safety databases. Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medications, • Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs), • Working experience with Safety Databases (Argus, ArisG or other) is required., • Knowledge of ICH E2B guidelines in clinical and post-marketing studies. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Director of Manufacturing San Diego, CA (North County) 180-220k About Us We are a leading company in the pharma sector, committed to delivering high-quality consumer products that enhance well-being. Our dedication to excellence in manufacturing and innovation has made us a respected name in the industry. We are seeking a highly skilled Director of Manufacturing to lead our operations and drive continued success. Position Overview The Director of Manufacturing will oversee all aspects of the production process, ensuring efficient operations and the delivery of top-quality products. This role involves leading a team of manufacturing professionals, optimizing processes, and collaborating with cross-functional teams to meet company objectives while maintaining rigorous safety and quality standards. Key Responsibilities • Strategic Leadership: Develop and execute plans to enhance manufacturing efficiency and achieve production targets aligned with organizational goals., • Team Management: Lead, mentor, and train a team of manufacturing professionals, fostering a culture of accountability, collaboration, and high performance., • Process Optimization: Identify and implement process improvements to reduce waste, increase productivity, and streamline operations., • Quality Assurance: Champion a quality-focused culture, integrating Lean Six Sigma tools and practices to ensure product excellence., • Regulatory Compliance: Ensure adherence to all relevant industry regulations and standards governing manufacturing and product safety., • Cost Management: Oversee budgets, monitor expenses, and drive cost-saving measures without compromising quality., • Cross-functional Collaboration: Partner with departments such as R&D, supply chain, and finance to support broader company objectives., • Continuous Improvement: Promote best practices and employee engagement to sustain a culture of operational excellence., • Performance Monitoring: Establish and track KPIs to assess performance and identify areas for improvement., • Education and Experience: Bachelor’s degree in Engineering or Operations Management (Master’s in Business Administration or Engineering preferred); 10+ years of manufacturing leadership experience, including 5+ years in a senior role. Proven experience in pharmaceutical/nutraceutical manufacturing processes., • Lean Manufacturing Expertise: Proven success with Lean principles (e.g., 5S, Kaizen) and Six Sigma Black Belt certification. Must have a solid understanding of equipment, automation, and processes - with proven time on the manufacturing floor., • Technical Skills: Strong engineering background with expertise in root cause analysis, troubleshooting, and high-volume production management., • Industry Knowledge: Familiarity with regulated manufacturing environments and compliance with standards like GMP and FDA regulations., • Leadership: Experience managing teams, optimizing labor resources, and implementing training programs., • Financial Acumen: Proficiency in budgeting, cost analysis, and financial forecasting., • Experience with advanced manufacturing technologies, such as automation or robotics., • Competitive salary and comprehensive benefits package., • Relocation assistance and performance-based incentives available.

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our growing organization as an on-site Associate Director / Director, Regulatory Affairs and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, and highly flexible within a fast-paced environment. The Assoc. Director / Director, RA is responsible for oversight and management for all of ADARx’s global regulatory filings and dossiers. Essential Responsibilities: • Accountability for managing the full life cycle of regulatory dossier preparation and submission including INDs, IMPDs, etc., • Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications., • Coordinate across functional teams to assemble and submit responses to regulatory inquiries during dossier/application review cycles., • Lead cross-functional teams to develop and to improve systems to increase efficiency of regulatory processes, including the development of Regulatory-specific SOPs., • Lead and/or support regulatory submissions, consultations, and other discussions with global regulators on digital health topics, including the FDA, notified bodies, in-country representatives, distributors, and other counsels., • Contribute to the preparation of research reports and presentations for internal project teams, leadership team members, and external audiences., • Presentation of results in both written and oral format and delivery of completed reports within a multidisciplinary team., • Promotes a team-oriented culture within and between departments., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company as well as external consultants as necessary., • Maintain all appropriate corporate standards for office and lab safety. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Bachelor’s degree or higher in a related field., • Minimum 6-12 years of biotech/pharmaceutical industry., • Minimum 2-5 years in a management role within Regulatory., • Experience in interfacing and responding to relevant global regulatory authorities., • Must have up to date understanding and knowledge of fundamental regulatory requirements for pharmaceuticals across a wide range of territories (e.g., FDA, EMA, MHRA, PMDA, ANVISA, TGA, etc.)., • Ability to travel domestically and internationally (10%)., • Must be able to work independently with supervision as needed., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Master’s degree and/or PhD a plus., • Regulatory Affairs Certification a plus., • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job DescriptionSalary: $110,000.00 - $130,000.00 - based on experience About Arthrosi Therapeutics Arthrosi Therapeutics is a clinical-stage biotech company committed to transforming the treatment paradigm for gout and related inflammatory diseases. Our lead candidate, AR882, is a best-in-class oral URAT1 inhibitor currently in Phase 3 clinical development. We are seeking to build a strong quality team that will play a pivotal role in our journey to regulatory approval and beyond. Position Summary The Quality System Manager, under the supervision of Quality Leadership, is responsible for executing and supporting day-to-day activities of GxP quality systems, with particular emphasis on document control, change control, and deviation management. This role ensures that quality processes are implemented in compliance with applicable regulatory requirements (FDA, EMA, ICH, ISO) and internal quality standards to maintain inspection readiness and support product development through commercialization Key Responsibilities Document Control • Administer the electronic Document Management System (eDMS) ensuring documents are created, reviewed, approved, distributed, and archived in compliance with regulatory and company standards., • Coordinate controlled document lifecycle: drafting, formatting, issuance, revision, retirement, and archival., • Maintain document templates, numbering systems, and access permissions., • Facilitate change control process by logging, tracking, and monitoring changes to GxP systems, procedures, and controlled documents., • Assist in risk assessment and impact analysis of proposed changes., • Coordinate cross-functional review and approval of change requests, ensuring timely closure., • Log and track deviations, errors, or nonconformances in the Quality Management System (QMS)., • Coordinate investigation activities, ensuring root cause analysis and appropriate corrective and preventive actions (CAPAs) are documented., • Monitor deviation and CAPA timelines to ensure compliance with internal metrics and regulatory expectations., • Administer the required training related to SOPs, policies, and GxP compliance., • Maintain accurate and complete quality records to ensure inspection readiness at all times., • Support preparation for internal audits, external audits, and regulatory inspections., • Generate routine metrics on document control, change control, deviations, and CAPA performance., • Proactively identify areas for process improvement within quality systems., • Support initiatives to streamline workflows, enhance compliance, and increase efficiency. Qualifications Education • 4-8 years of experience in a GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry)., • Experience with electronic Quality Management Systems (eQMS), Document Management Systems, or, • Understanding of FDA, EMA, and ICH GxP regulations and guidelines., • Strong organizational and time-management skills with ability to manage multiple priorities., • Excellent written and verbal communication skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook)., • Attention to detail and commitment to data integrity Preferred Attributes • Prior experience working in a company advancing a product from late-stage development to commercial launch., • Hands-on experience implementing or scaling electronic QMS tools and inspection readiness platforms. Why Join Arthrosi? • Opportunity to make a significant contribution to addressing a disease with significant unmet medical need., • Opportunity to make a significant impact in a small, agile organization advancing a promising late-stage oral therapeutic., • Dynamic and collaborative environment where science, innovation, and execution come together., • Competitive compensation and equity participation with high-growth potential., • Flexible work model and a mission-driven culture anchored in scientific excellence and patient impact.

Job Description We are seeking a highly motivated and qualified leader to join ADARx Pharmaceuticals as a Director of Medical Writing and Clinical Science to lead medical writing strategies aligned with clinical and regulatory goals and execution across clinical development programs. The successful candidate will provide scientific leadership through clinical development, regulatory submissions, and post-marketing activities. This role is ideal for an individual who thrives in a fast-paced, high-growth environment and is passionate about making a meaningful impact in drug development. Essential Responsibilities: • Lead the planning, authoring, and on-time delivery of regulatory and clinical documents in accordance with the corporate timeline, including:, • Clinical trial protocols/amendments, • Clinical Study Reports (CSRs), • Investigator’s Brochures (IBs), • Regulatory submission documents (IND/CTA, NDA/BLA/MAA, briefing books), • Clinical summaries for eCTD modules, • Conduct version management and tracking of drafts and final document and ensure compliance with global regulatory standards (e.g. FDA, EMA, ICH-GCP)., • Coordinating with document management systems and archiving finalized documents for audits and inspections., • Verify 100% accuracy of data against source documents, • Develop and maintain templates, style guides, and best practices for medical writing tailored to RNA-based drug development., • Provide scientific leadership in the design, execution, and interpretation of clinical studies in RNA therapeutics across all phases of development., • Collaborate with clinical operations, clinical development, biostatistics, regulatory affairs, safety, and CMC teams to align timelines and messaging complex scientific data into clear and compliant content., • Author and review of protocols, IBs, CSRs, and regulatory submissions with scientific accuracy and strategic alignment., • Support preparation and delivery of scientific presentations and publications (abstracts/posters), investigator meetings, and advisory boards., • Contribute to the preparation of clinical development strategies, including dose selection, endpoint justification, and interpretation of pharmacokinetic/pharmacodynamic data., • Oversee internal and external medical writing teams, as applicable, including CRO partners, ensuring compliance with regulatory standards (e.g., FDA, EMA, ICH). Evaluates and manages CRO for applicable scope, timelines and deliverables., • Mentor and develop junior medical writers, while contributing to building medical writing capabilities and infrastructure within the company for exceptional cross-functional collaboration., • Stay current with evolving regulatory requirements, industry trends, and methodological innovations relevant to medical writing and clinical data review with special focus on RNA therapeutics., • Drive continuous improvement of processes, tools, and workflows to increase efficiency and quality., • Creates, maintains, and implements SOPs, processes, standards, and work instructions with respect to medical writing to ensure compliance, accuracy, and efficiency. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is preferred, although remote candidates will be considered for this role. The Company deems full critical engagement to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Advanced degree in life sciences (PhD, MD, PharmD or MSc) with strong background in molecular biology, pharmacology, or related fields preferred., • 10+ years of experience in biotech/pharmaceutical industry with a blend of clinical science and medical writing responsibilities., • Expertise in regulatory writing and clinical development for RNA therapeutics, oligonucleotides, gene therapies, or biologics (strongly preferred)., • Proven track record contributing to or leading major regulatory submissions (IND/CTA, NDA/BLA/MAA)., • Strong understanding of clinical trial design, pharmacology, and RNA-specific therapeutic considerations (delivery, immunogenicity, biodistribution)., • Exceptional communication, writing, and editing skills with the ability to distill complex science for diverse audiences., • Leadership experience managing cross-functional teams and external vendors., • Strategic thinker with the ability to integrate science and regulatory strategy., • Passion for advancing RNA-based therapies to address unmet medical needs., • Comfortable working in a fast-paced, entrepreneurial biotech environment., • Must be able to work independently with supervision as needed., • Must be collaborative, work well with other Clinical Development team members in a matrix team environment., • Excellent written and verbal communication skills are essential for this role., • Strong organizational skills with attention to detail and accuracy., • Ability to maintain a high level of confidentiality and exercise discretion., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges., • This is a full-time position, Monday-Friday., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors. Disclosure Statement • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description We are seeking a dynamic and results-driven Marketing Manager to lead the development and execution of marketing strategies for CorDx’s In Vitro Diagnostics (IVD) product portfolio. This role will focus on product marketing, brand positioning, digital marketing initiatives, and commercial enablement in alignment with business growth objectives. The ideal candidate will have experience in the medical device or diagnostics industry, a strong understanding of B2B healthcare marketing, and the ability to thrive in a fast-paced, collaborative environment. Key Responsibilities:1. Product Marketing & Positioning • Develop and implement marketing plans to support product launches, market expansion, and customer acquisition initiatives., • Define product positioning, key messaging, and value propositions tailored to different customer segments and geographies., • Conduct competitive analysis and market research to identify opportunities and support commercial strategies. 2. Marketing Communications & Content Development, • Lead the creation of marketing content, including sales collateral, brochures, product datasheets, case studies, and digital assets., • Manage marketing campaigns across multiple channels, including email marketing, social media, tradeshows, and industry events., • Collaborate with internal stakeholders to ensure consistent brand messaging and compliance with regulatory standards. 3. Digital & Demand Generation, • Develop digital marketing strategies to drive awareness, lead generation, and customer engagement., • Manage website content, online campaigns, and social media presence to promote CorDx’s diagnostic solutions., • Track campaign performance metrics and optimize tactics based on data-driven insights. 4. Sales Enablement & Commercial Support, • Partner with the Sales and Business Development teams to deliver marketing tools, presentations, and training materials., • Support pricing strategies, product promotions, and marketing initiatives aligned with revenue goals., • Gather customer and market feedback to influence product development and commercial strategies. 5. Event Management & Industry Engagement, • Plan and manage CorDx’s presence at industry conferences, exhibitions, webinars, and partner events., • Required Qualifications:, • Bachelor’s degree in Marketing, Life Sciences, Business Administration, or a related field. An MBA is a plus., • 5+ years of marketing experience, preferably within the biotech, diagnostics, medical device, or life sciences industry., • Strong background in product marketing, digital marketing, and B2B commercial marketing., • Excellent written and verbal communication skills, with the ability to develop clear, compelling marketing materials., • Proficiency with marketing platforms, CRM systems, and digital tools., • Strong organizational and project management skills, with the ability to manage multiple priorities., • Preferred Qualifications:, • Experience supporting IVD or OTC, point-of-care diagnostic product launches., • Familiarity with FDA, ISO 13485, and healthcare marketing compliance requirements., • Experience in global or multi-regional marketing campaigns., • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job Description PURPOSE Operates under the direct supervision Operations Supervisor. Follows and adheres to buyer specifications. Ensure there are no out-of-compliance conditions when processing the plasma or samples. Complete tasks accurately and in compliance, to set the example for employees under their lead. General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards. ESSENTIAL RESPONSIBILITIES & DUTIES • Ensure product integrity by ensuring compliance with Food and Drug Administration (FDA) regulations, state regulations, ABO’s Standard Operating Procedures (SOP), and any other applicable regulatory standards., • Organize product in storage freezer, ensuring freezer organization is complete and consistent., • Perform the QA review of donor samples., • Perform the QA review of product to be shipped to the consignee., • Assist with the process flow in the lab, ensuring the bottles are entering the freezer in the proper time frame., • Coordinate Daily Activities in Processing Area, • Make daily assignment in coordination with manager, • Provide preventive maintenance as scheduled on equipment: centrifuge, heat sealers, thermometer, internal freezer thermometers and graph recorders, and calibrate as necessary, • Observe technicians for compliance, • Assist with destroying unacceptable units. Quarantine and discard unacceptable samples and products., • Manage flow of units coming through the window and ensure compliance in accordance with the SOP., • Facilitate training of new lab team members in coordination., • Set up, operate and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control)., • Maintain instruments used for processing and storage of donor samples and products., • Document operational and maintenance activities when necessary., • Determine supply inventory requirements; order and restock, as needed., • Communicate delays and other issues to center management, and/or other necessary parties., • Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated., • Any other duties as assigned. REQUIREMENTS • High school diploma or equivalent (Must be able to show proof), • Strong customer service skills., • Must be proficient in English (Read, Write, Speak) with legible handwriting, • Current CPR card, • Proficient with computer entry, • Prior supervisory skills preferred, • Certified as a Trainer, • Six months’ experience in plasma processing (Requirements can be changed by Management, depending on knowledge, skills and abilities.), • May be required to travel for training, • Bilingual (English/Spanish) PHYSICAL DEMANDS Performing the responsibilities of the job requires ability to use hands and fingers to handle and feel objects, tools or controls; reach with hands and arms. Frequently required to stand, walk, climb and balance; and stoop, kneel, or crouch. Required to stand for extended periods of time (2-4 hour intervals). Ability to lift, tug, and pull up to 50 pounds. WORK ENVIRONMENT This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May be exposed to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as protective eyewear, lab coat, gloves and freezer jacket/gloves/pants. Work in a walk-in freezer for short intervals of time (-20C or colder).

Job Description REMOTE Quality Engineer, SME - Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a REMOTE Quality Engineer, SME with a biotech company in San Diego, CA for applicants who exclusively possesses: • An advanced degree (M.S., or Ph.D.) in Analytical Chemistry, Pharmaceutical Sciences, or a related field is preferred., • 3+ years of industry analytical method development to support cleaning validation, • Direct experience with swab recovery studies for cleaning validation, • Proven hands-on experience with LC-MS, HPLC, and TOC testing. FULL DESCRIPTION: We are seeking an experienced Quality Control Subject Matter Expert (QC SME) to support a project focused on cleaning validation for small-molecule biopharmaceutical manufacturing. The role requires expertise in analytical methods such as LC-MS, HPLC, and TOC, as well as cleaning verification laboratory studies using industry-standard techniques. All project-related expenses will be covered in accordance with the client's policies. The selected candidate will be responsible for: • Design and execute cleaning swab recovery studies for small-molecule products using a representative surrogate and cytotoxic payload, following existing template protocols., • Understand analytical test methods such as LC-MS, HPLC, and TOC for swabs., • Qualify representative surrogate compounds using USP/EU Compendial test methods for cleaning validation programs., • Generate and review protocols, reports, and supporting documentation using client template protocols and report formats that align with FDA, EMA, and PIC/S expectations., • Collaborate with site teams in South Korea to conduct onsite laboratory and validation activities., • Provide remote technical support for protocol development and summary report writing, and support the execution of swab and recovery studies onsite. The selected candidate will also possess: • An advanced degree (B.S., M.S., or Ph.D.) in Analytical Chemistry, Pharmaceutical Sciences, or a related field is preferred., • 5+ years of experience in analytical method validation and cleaning verification., • Proven hands-on experience with LC-MS, HPLC, and TOC testing., • Direct experience with swab recovery studies for cleaning validation., • Familiarity with global regulatory guidelines (FDA, EMA, ICH, PIC/S)., • Strong technical writing and documentation skills., • Availability to travel and work onsite in South Korea for at least one month during the assignment. Salary Range: $65/hr For immediate and confidential consideration, please email your resume to or call 858.279.4902. More information can be found at

Job DescriptionAbout Truvian Truvian is a fast-paced, disruptive healthcare company at the intersection of diagnostics and consumer technology. We’re building a fully automated, benchtop diagnostic system that delivers lab-accurate results from a small blood sample in just 30 minutes. Designed for retail clinics and private practices, our platform is currently undergoing FDA review and aims to revolutionize routine blood testing by making it more accessible, affordable, and actionable. At Truvian, our mission goes beyond the lab. We are committed to empowering individuals with timely health data and fostering a culture of innovation, collaboration, and discovery. Join us and help realize our vision of transforming routine health testing for today’s connected consumers. Position Summary Truvian is seeking an experienced and hands-on Regulatory Affairs Director to lead and execute all aspects of the company’s global regulatory strategy. This leadership role will be responsible for supporting regulatory submissions and product registrations across domestic and international markets, ensuring compliance with applicable regulations, and enabling timely product commercialization. The ideal candidate must have extensive experience in the in vitro diagnostics (IVD) industry, with a strong track record of leading both FDA 510(k) and CLIA Waiver submissions through to successful clearance. This individual will work cross-functionally with internal stakeholders, regulatory bodies, and international partners to ensure our technology meets all applicable requirements while aligning with Truvian’s mission to transform diagnostic testing. This position is onsite and reports to the Head of Quality & Regulatory. This is a high-impact, hands-on role based at our corporate headquarters in San Diego, California. Key Responsibilities • Support the regulatory strategy for Truvian’s portfolio of IVD products, ensuring proactive planning and timely execution of submissions to FDA (510(k), CLIA Waiver), Health Canada, European Notified Bodies (CE Mark/IVDR), and other international agencies., • Support the end-to-end regulatory submission process, including the development of submission dossiers, gap assessments, pre-submissions, and agency interactions., • Work with the regulatory team to ensure a comprehensive regulatory roadmap aligned with product development and commercialization milestones., • Provide regulatory guidance during all phases of product development, from concept through design transfer, clinical validation, and market launch., • Ensure all product documentation, including labeling, advertising, and promotional materials, meets regulatory requirements., • Interpret and communicate complex regulatory requirements to internal stakeholders in a clear and actionable manner., • Support regulatory impact assessments of product and process changes; oversee documentation updates and change control., • Monitor and implement evolving global regulatory requirements (e.g., IVDR transition, ISO 13485 updates) and translate them into internal strategies and processes., • Support post-market regulatory activities, including vigilance reporting, field actions, and annual reporting obligations., • Bachelor’s degree in Life Sciences, Engineering, or a related discipline required; advanced degree (MS, PhD) strongly preferred., • 12+ years of experience in Regulatory Affairs, with a minimum of 8 years in the IVD industry., • Proven success leading and managing FDA 510(k) and CLIA Waiver submissions and approvals; experience with De Novo submissions is a plus., • In-depth knowledge of U.S. FDA regulations, CLIA requirements, EU IVDR, ISO 13485, and other global regulatory standards relevant to IVDs., • RAC certification preferred (U.S., Global, or EU)., • Demonstrated ability to translate complex regulatory guidance into practical regulatory strategies., • Experience interfacing with regulatory bodies, including preparation for and participation in agency meetings and audits., • Strong organizational, project management, technical, and analytical skills, with a high level of attention to detail., • Exceptional verbal and written communication skills, including the ability to influence and lead cross-functional teams., • Impactful Mission: Join a passionate team revolutionizing point-of-care blood diagnostics and making a tangible difference in healthcare access., • High-Energy Environment: Thrive in a fast-paced, high-growth startup that values innovation, collaboration, and purpose., • Comprehensive Benefits Package, including:, • Medical, Dental, Vision, and Life Insurance, • Flexible Paid Time Off (PTO) and Paid Parental Leave, • 401(k) plan with generous company match, • Wellness Perks:, • On-site gym and fitness classes, • Access to a farm-to-table café with a 30% employee discount, • $168,000 - $186,000, • Ability to lift and move up to 5 lbs., • Frequently standing and sitting for long periods. Equal Opportunity Employer Truvian is an Equal Opportunity Employer. We are committed to building a diverse and inclusive team where everyone belongs and thrives. All employment decisions are made based on qualifications, merit, and business needs — never based on race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status. Powered by JazzHR YTV8C5WPWh

Job Description Quality Assurance Inspector I Monday - Friday, 8:30am - 5:00pm About Us At Argen, we’re in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. We have a team of 400 Awesome team members. Founded more than 50 years ago as a precious metals company in South Africa, Argen has grown to become the largest dental zirconia manufacturer in North America, largest dental alloy provider worldwide, and leader in digital dentistry solutions with a product offering that span fixed, removable, ortho, implants, and equipment. Our 140,000 square foot manufacturing center houses more than 150 3D printing and milling machines and operates six days a week. Argen’s products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed. About the Opportunity The Quality Assurance Inspector I plays a pivotal role in ensuring the quality and integrity of Argen products. Inspects works in-process and finished goods in manufacturing areas to ensure conformance as defined by ISO 13485:2016, FDA regulated standards, customer specifications, Argen requirements, and applicable procedures. In this role, the successful candidate will: • Provides in-process/final inspection and testing as required., • Performs visual inspections of finished products., • Participates in internal assessments and audits as required., • Maintains proper inspection and test records., • Assures that non-conforming material has been properly identified., • Advises the responsible production personnel of the acceptability of products or materials based on results of testing and/or inspection., • Provides solutions to technical problems and assists on special projects., • Maintains lot traceability, log sheets, and good housekeeping practices at all times., • Maintains a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner., • Ensure that lab cleanliness and safety standards are maintained., • Performs thorough inspections during and after the production process to ensure product quality and compliance with standards., • Verifies that all product labeling is accurate, compliant, and meets regulatory requirements., • Ensures that production lines are properly cleared and prepared for the next production run, maintaining cleanliness and order., • Examines and validates DHRs to ensure all documentation is complete, accurate, and in compliance with regulatory and company standards., • Other duties as assigned. What does it take to be successful? • High school diploma or equivalent required., • Previous experience working in a GMP facility a plus., • 8 hours of Quality Training (PTC) required., • Strong attention to detail., • Knowledge of basic arithmetic and application to solve problems., • Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods., • Knowledge of computer skills, administrative and office procedures and systems., • Communicating effectively in writing as appropriate for the needs of the audience., • Technical skills and ability to understand drawings, artworks and procedures., • Talking to others to convey information effectively., • Perform duties with the highest regard for safety and quality., • Ability to understand and follow site protocols, policies and procedures, • Must be flexible, forward- thinking, motivated, and have the ability to act independently., • Ability to prioritize tasks and meet deadlines., • Problem-solving skills., • Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training., • Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred. Our Awesome Benefits! Working for a growing innovative company like Argen means exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, Argen is committed to ensuring the welfare of its employees and provides an amazing benefit package that includes: • Health Plans, • Dental Plans, • Vision Plan, • 401k with Employer Match, • Paid Time Off and Paid Holidays, • Employee Events, • Wellness Programs, • Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more! EOE/M/F/Vet/Disabled VEVRAA Federal Contractor

Job DescriptionAbout Truvian Truvian is a fast-paced and disruptive healthcare company at the intersection of diagnostics and consumer technology. We are developing a fully automated benchtop system that delivers lab-accurate results from a small blood sample under 30 minutes—designed for use in retail clinics or private practice settings. Our proprietary platform, currently under FDA review, is built to make routine blood testing more accessible, affordable, and actionable. At Truvian, we’re not just building a product—we’re building a movement to empower people with better health data, on demand. We are a team of trailblazers committed to discovery, collaboration, and innovation. If you’re looking for meaningful work in a mission-driven environment, join us on our journey to transform healthcare. Position Summary Truvian is seeking a Staff Biostatistician to provide strategic and technical leadership in biostatistics for analytical and clinical study design, execution, and analysis. This is a hands-on role where you will lead statistical strategy while also performing analyses that contribute directly to regulatory filings, publications, and internal data reviews. You will work cross-functionally with teams in product development, regulatory affairs, scientific affairs, and marketing, playing a pivotal role in validating Truvian’s blood testing technology for market readiness. Here’s Why You’ll Love This Job • Lead statistical strategy for a breakthrough technology in diagnostic healthcare., • Contribute to a high-impact product launch and shape the future of patient-centered diagnostics., • Collaborate with passionate, mission-driven professionals in a fast-paced, agile work environment., • Enjoy perks including:, • Medical, dental, and vision coverage, • 401(k) plan, • Paid parental leave and flexible PTO, • Craft coffee, cold brew, and kombucha on tap, • Healthy snacks and a farm-to-table restaurant with an employee discount, • Provide statistical leadership for analytical and clinical studies across the product lifecycle., • Design protocols and statistical analysis plans; conduct analyses supporting regulatory submissions, validations, and publications., • Lead clinical trial statistical components, including sample size calculations and endpoint analyses (e.g., sensitivity, specificity, PPV, NPV)., • Perform data quality control and ensure consistency, accuracy, and regulatory compliance., • Prepare study reports, regulatory documentation, and scientific presentations., • Integrate data from multiple sources to drive evidence-based decision-making., • Support analytical verification and clinical validation efforts per CLSI guidelines., • Ph.D. in Biostatistics, Statistics, or a related field with 5+ years of industry experience, OR M.S. with 8+ years, OR B.S. with 12+ years in biostatistics within the IVD or Biotech space., • Proven experience designing and analyzing clinical and analytical studies for IVDs., • Strong working knowledge of regulatory frameworks and design control processes., • Proficiency with statistical software (e.g., R, Python, SAS, JMP, SPSS, Alteryx, Analyse-It)., • Deep understanding of clinical accuracy metrics and statistical methods for diagnostics., • Strong written and verbal communication skills to clearly explain statistical insights., • Ability to work independently in a startup environment and manage competing priorities. Physical Demands • Ability to lift and move up to 5 lbs. regularly, • Sitting and standing for long periods of time, • $164,000 – $200,000The salary range reflects a wide set of factors, including experience, education, skills, certifications, and organizational needs. Final compensation will be determined based on qualifications and internal equity. Equal Opportunity Employer Truvian is an equal opportunity employer and is committed to fostering an inclusive and diverse workplace. We welcome all qualified applicants regardless of race, color, religion, sex, gender identity, national origin, disability, age, or veteran status. Cover letters are strongly encouraged. Powered by JazzHR LgZkmtTYvC

Job Description The Environmental Health and Safety Technician II, supports the Environmental Health and Safety (EHS) team in implementing and maintaining various EHS programs. Assists in identifying workplace hazards, conducting inspections, and ensuring compliance with relevant regulations. Organizes, schedules and conducts higher level inspections of facilities, work areas and equipment. Monitors site conditions, practices, and procedures for compliance with health and safety requirements. Collaborates with other departments to promote safety and environmental awareness. Selects and implements corrective action and follows-up to ensure proper action has been taken. Schedule: Monday – Friday 8:00 am – 4:30 pm In this role, the successful candidate will: • Performs all jobs in a safe and responsible manner, following all SOP’s and safety requirements., • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices., • Maintains working knowledge of all EHS regulatory requirements that affect the company., • Recognize hazards, and assist in providing corrective action to eliminate or mitigate identified hazards., • Assists in the maintenance of operating permits, licenses, registrations and reports required by governmental agencies that conform to EHS related laws and regulations., • Facilitates the removal of the hazardous waste stream at all sites., • Performs daily check as per instructions on industrial waste water system., • Actively promotes a culture of safety where employees can develop confidence in ability to participate in company safety programs., • Assists with regular safety audits on life safety equipment for accessibility and functionality at all sites., • Assists with regular safety audits to ensure Personal Protective Equipment compliance as required by company policy and local regulations., • Responds to all alarms and hazardous waste spills., • Assists with internal safety audits to assure compliance with company policies., • Participates in training to keep up-to-date with regulatory agency rules and compliance matters., • Educate, monitor, and train personnel in safe work procedures., • On-site escort of contractors and vendors., • On-call responder for alarm calls, 24/7 coverage., • Conduct thorough and routine safety inspections, identifying potential hazards and recommending corrective actions., • Assist in incident investigations, performing root cause analysis, and preparing detailed reports., • Support the development and delivery of EHS training programs for employees and contractors., • Ensure compliance with local, state, and federal EHS regulations and permits., • Participate in emergency response planning and drills., • Assist in the management of hazardous materials, including storage and disposal., • Collaborate with cross-functional teams to implement EHS initiatives., • Help develop and update EHS policies and procedures to align with changing regulations., • Maintain EHS records and documentation, ensuring accuracy and completeness., • Associate degree or higher, in environmental health safety or related field, discipline preferred, or equivalent combination of education, training, and experience., • Two or more years of experience as an EHS Technician or in a similar EHS role., • Working knowledge of federal, state and local related laws and regulations., • Solid understanding of EHS regulations and best practices., • Experience in incident investigation and root cause analysis., • Strong communication and interpersonal skills., • Proficiency in MS Office applications and EHS software tools., • Ability to work independently and collaboratively in a team environment., • Preferred Department of Transportation Hazardous Materials Transportation certificate (49 CFR 172.704), • Health Plans, • Dental Plans, • Vision Plan, • 401k with Employer Match, • Paid Time Off and Paid Holidays, • Discounts for home, travel, entertainment and relaxation! About Us Argen is a family-owned and privately held company based in San Diego, CA with a state-of-the-art manufacturing center that provides high quality dental solutions to dental labs of all sizes. Founded as a precious metals company in South Africa, Argen has evolved into a dynamic, technology-based manufacturing organization focused on three key business segments, including dental alloys, zirconia, and digital dentistry solutions. Argen continues to invest in innovative product improvement initiatives through its Quality Management System to provide our global customers with affordable, high-performance products and industry-leading excellent service. Argen’s products are FDA regulated and ISO certified.

Job DescriptionTravel: 30%Position Summary: Natera is seeking a Senior Marketing Manager to lead marketing strategy and execution for Signatera, our personalized molecular residual disease (MRD) test, with a focus on gastrointestinal (GI) cancers. This role is critical in driving adoption and integration of Signatera into standard of care for GI oncology. The ideal candidate brings a passion for oncology innovation, deep marketing expertise, and the ability to communicate complex scientific value simply and effectively. This individual will report to the Associate Director Oncology Marketing, GI Cancers. Primary Responsibilities: • Develop and execute strategic and tactical marketing plans to drive growth of Signatera in GI cancers and other solid tumors., • Track and analyze product performance metrics to identify growth opportunities and close gaps to target., • Lead the development of field and digital marketing collateral, ensuring alignment with current clinical data and strategic priorities., • Collaborate cross-functionally with medical affairs, field sales, digital, regulatory, legal, and external vendors to execute on marketing initiatives.Qualifications:, • Bachelor's degree in life sciences or related field required; advanced degree (MBA, PhD) preferred., • 5–7 years of experience in product marketing, field sales, or market analytics within diagnostics, biotech, or pharmaceutical industries., • Experience in oncology and/or genomics highly preferred., • Familiarity with FDA-approved treatments and the clinical landscape in GI cancers is a strong plus.Knowledge, Skills & Abilities:, • Strategic thinker with strong business acumen and ability to operate with executive presence., • Effective collaborator across internal teams and external stakeholders, including thought leaders., • Strong customer orientation with an ability to distill complex scientific content into clear, value-driven messaging., • Excellent written and verbal communication skills., • Outstanding organizational and time management skills; ability to manage multiple projects simultaneously and deliver high-quality results., • Demonstrated success in developing and managing key opinion leader relationships and external partnerships. Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit . Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: • BBB announcement on job scams, • FBI Cyber Crime resource page

Job Description COMPANY OVERVIEW: Alliance Clinical Network we’re people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research. We bring our energy and our passion to improving patient lives every day. SUMMARY: The Clinical Research Coordinator I supports the conduct of clinical trials by coordinating study visits, managing data collection, and ensuring compliance with protocols and regulatory guidelines. This role involves direct interaction with participants and plays a key part in maintaining study integrity and quality. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Communicate clearly and professionally with study participants regarding study objectives and ongoing instructions., • Administer questionnaires and monitor participant compliance with study protocols., • Respond to participant needs promptly and appropriately., • Collect and document patient medical history and health conditions., • Obtain and document informed consent from study participants., • Maintain accurate records of study drug dispensation and accountability., • Coordinate with laboratories to ensure timely testing and reporting., • Collect and assess information on concomitant medications., • Review and evaluate medical records for protocol compliance., • Perform and document assessments for adverse events (AEs) and serious adverse events (SAEs)., • Conduct clinical procedures including EKGs, vital signs, nasal swabs, and other protocol-specific tasks., • Review and evaluate clinical laboratory reports., • Maintain up-to-date regulatory files for the research site., • Verify the accuracy and completeness of collected data., • Monitor and document temperatures for investigational product (IP) storage., • Support recruitment and engagement of study participants as needed., • Develop electronic source (e-source) documents in accordance with study protocols., • Manage study startup documentation, training, and timelines for assigned protocols., • Ensure all protocol requirements and deadlines are met consistently., • Adhere to all company policies, procedures, and code of conduct. EDUCATION AND EXPREIENCE: • At least 1 year of experience with phlebotomy and EKG procedures, with a current Phlebotomy (CPT) license (required), • Associate’s degree in healthcare or a related field, or equivalent relevant experience, • 2+ years of experience in clinical research trials, • 2+ years of experience with FDA regulations and Good Clinical Practice (GCP), • Demonstrated analytical reasoning skills, • Exceptional attention to detail and strong organizational skills, • Excellent verbal and written communication abilities WORK LOCATION: San Diego, California BENEFITS: • 401 (k) Retirement Plan, • Medical, Dental, and Vision Insurance, • Paid Time Off (PTO), • Floating Holidays, • And more!

Job Description FEFA, LLC seeks a Clinical Program Manager to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. The OID Directorate conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. This position will support research on infectious pathogens affecting military personnel and advance studies related to pathogen biology, host-pathogen interactions, and disease transmission. This role will primarily be responsible for overseeing day-to-day project operations, ensuring contract compliance, managing resources, and serving as the primary point of contact for the client and internal teams. Compensation: $105,000.00-125,000.00 per year. Key Responsibilities: • Lead the planning and implementation of project tasks, ensuring timely execution within scope and budget, • Interface regularly with the client, vendors, and internal stakeholders to ensure effective communication and project alignment, • Develop and maintain project documentation, schedules, and status reports, • Oversee onboarding and tasking of project personnel, ensuring role clarity and resource optimization, • Manage deliverables, track milestones, and proactively identify risks and mitigation strategies, • Provide regular updates to program leadership and ensure client satisfaction Project Management & Coordination • Provides day-to-day supervision of department-based research staff, ensuring efficient coordination of clinical research projects., • Manages the lifecycle of clinical research and bio surveillance studies, from protocol development through study implementation, data collection, and reporting., • Collaborates with internal and external stakeholders, including researchers, clinicians, sponsors, and regulatory bodies, to ensure smooth project execution., • Monitors project timelines, deliverables, and milestones, ensuring adherence to deadlines and budgets. Responsible for writing and reviewing monthly reports Budget Development & Management • Develops, negotiates, and monitors project budgets related to funded research initiatives., • Tracks and manages expenses, ensuring that projects remain within budget and align with the OID Directorate’s financial objectives., • Provides financial reports and updates to leadership, sponsors, and other key stakeholders as required. Regulatory Compliance & Quality Assurance • Ensures that all clinical research projects comply with Institutional Review Board (IRB) requirements, Good Clinical Practice (GCP) guidelines, and relevant federal regulations., • Monitors for quality assurance throughout the clinical research process, conducting regular reviews of data accuracy, regulatory compliance, and adherence to study protocols., • Oversees the preparation and submission of regulatory documents, reports, and study-related correspondence. Staff Supervision & Development • Supervises and mentors clinical research staff, providing guidance and support to ensure high performance and professional growth., • Assigns responsibilities, oversees workload distribution, and conducts regular performance evaluations of clinical research team members., • Facilitates training opportunities for staff to stay current with clinical research best practices, regulatory requirements, and relevant scientific advancements., • Coordinate with public health, clinical, and operational partners to support timely data reporting and analysis. Direct and manage bio surveillance operations, integrating epidemiological data, syndromic surveillance, and lab results to identify and respond to emerging threats. Stakeholder Communication & Reporting • Serves as the primary point of contact for sponsors, funding agencies, and external partners, ensuring timely communication and coordination throughout the project lifecycle., • Prepares and presents project updates, progress reports, and final study findings to NHRC leadership and other stakeholders., • Participates in the writing and editing of scientific publications, abstracts, and presentations related to clinical research findings., • Develop and refine surveillance protocols, data-sharing agreements, and emergency response procedures. Team Leadership & Supervision: • Supervise and mentor a multidisciplinary team of research coordinators, clinical staff, and bio surveillance analysts., • Conduct performance evaluations, facilitate professional development, and support staff in meeting deliverables., • Foster a culture of collaboration, accountability, and scientific integrity. Regulatory & Compliance: • Ensure compliance with IRB requirements, DoD/NIH/FDA policies, and institutional procedures., • Maintain accurate records and support audit readiness through comprehensive documentation., • Manage adverse event reporting, protocol deviations, and other regulatory submissions. Strategic Planning & Communication: • Develop project plans, manage timelines, and lead initiatives under tight deadlines and high-pressure environments., • Support strategic planning for long-term research and surveillance priorities., • Communicate progress and findings clearly to leadership, sponsors, collaborators, and external partners. Other Duties as Assigned Qualifications: • Bachelor’s degree in Science, or related field (Master’s in public health or business is preferred), • PMP or equivalent project management certification (preferred), • Minimum 5 years of experience managing research projects/programs or similar complex projects with at least 2 years in a supervisory or leadership role, • Strong working knowledge of project management software (e.g., MS Project, Smartsheet), • Excellent communication, leadership, and organizational skills · Familiarity with REDCap, CTMS, or other clinical trial management platforms. · Clinical research certification (e.g., CCRC, CCRP) strongly preferred. Soft Skills Required: · Proactive Leadership & Communication: Effectively leads cross-functional teams, fosters collaboration, and communicates complex concepts clearly across clinical, research, and operational stakeholders. · Adaptability Under Pressure: Maintains composure and focus in high-stakes environments, adjusting to evolving priorities and tight timelines without compromising quality. · Strategic Thinking & Problem Solving: Anticipates challenges and identifies solutions, continuously looking for research growth opportunities, in both clinical trials and bio surveillance settings. · Emotional Intelligence & Team Development: Builds trust, supports staff development, manages change and demonstrates empathy and professionalism in all interactions. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19, and proof of vaccination may be required. Benefits FEFA, LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.

Job Description Now is a great time to join our growing company! The Millennium Group (TMG) is an award-winning business process outsourcing firm focused on print, mail, document scanning, reception, and related office support services for Fortune 500 companies, professional service firms, and institutions of higher education. TMG is looking for highly motivated, enthusiastic team players interested in a career rather than just a job. With a team of over 1,500 nationwide associates, TMG is seeking an individual who can uniquely contribute to our 30+ years of success in the industry. Responsibilities: • Coordinates Shipping and Receiving services and administrative functions., • Oversees all functions and operations of the Shipping and Receiving area while supporting Facilities supplies / parts inventory and mail / copy rooms. Delegates tasks when required, • Performs and reviews data entry, filing and maintenance of documentation supporting all Shipping and Receiving transactions, • Processes and audits all incoming deliveries for accuracy and completeness, • Compares identifying information and counts, weighs, or measures items of incoming and outgoing shipments to verify information against bills of lading, invoices, orders, or other records, • Oversees and performs examination of incoming shipments, rejects damaged items, records shortages, and corresponds with shipper / customer to rectify damages and shortages, • Provides data for monthly metrics and discusses with staff to assess work volume and address operational concerns (volume packages received and shipped), • Oversees and performs cross-training of back up staff in Shipping & Receiving procedures, • Delivers critical cold packages to end users in a timely and efficient manner, • Prepares, packages and ships requested packages per DOT / IATA guidelines, • Works with Customs and Brokers as needed to resolve any shipment issues, • Performs and oversees incoming / outgoing mail and package delivery tasks, • Provides procurement system and budgetary oversight., • Resolves all receiving issues with Finance, Accounting and Purchasing, • Oversees and performs reconciliation of all received orders and receipts, • Supports Facilities operating budget within target goals for all contracted services and expenses, • Oversees and performs ordering and delivery of dry ice as needed to labs, • Provides guidance to customers on shipping options to minimize unnecessary shipping costs, • Orders, stocks, organizes and maintains general office supplies, warehouse, mailroom and copy area supplies, • Contributes to the capital and expense forecasting process, • Reviews and interprets service contractor performance and provides recommendations., • Initiates and manages projects of moderate scope and complexity within their functional area., • Serves as a Shipping & Receiving site representative during interactions with all cross functional groups, as required, • Collaborates with Corporate and other site's Shipping & Receiving to align processes and procedures, • Provides support with contract management including scope of work, cost assessment, and documentation, • Manages the selling, liquidation or donation of all used equipment as directed, • Oversees and coordinates the scheduling and pick up of all recyclable materials, • Participates in process cost savings and improvement initiatives., • Promotes and provides excellent customer service and support., • Acts as a liaison in providing technical or logistics guidance to our site customers and contracted service providers, • Interfaces with R&D customers and provides guidance on business-related issues to ensure all expectations are being met, • Maintains a positive relationship with all the members of the Facilities department and our site customers while promoting a positive team environment, • Oversees work and customer communications to minimize impact to site operations., • Maintains compliance with corporate, safety, security and regulatory policies., • Acts as a liaison with EH&S staff to ensure a safe working environment, as required, • Maintains all assigned Corporate, Facilities and EHS training as required, • Ensures staff and contracted service providers perform all tasks in a safe manner. Qualifications: • High School diploma, • Minimum 4 years experience in a Shipping/Receiving environment or equivalent work experience., • Current DOT / IATA training certification, • Current Hazardous Materials training certification, • Ability to invest time, as required, expediting or completing assignments which may necessitate working evening and / or weekend hours as necessary to meet business demands, • High level computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook with strong background in database systems. Ability to learn new software, such as enterprise business, • Firm knowledge of enterprise business systems such as Oracle or SAP, and firm understanding of purchase requisition submissions and purchase order generation systems, • Strong written and verbal communication skills. Proficient with writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation., • Excellent interpersonal skills with experience dealing with a diverse workforce, • Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously., • Experience in coordinating outside contractors in support of C-TPAT requirements for shipping and receiving operations, • Familiarity with Injury and Illness Prevention Plans (IIPP), Chemical Hygiene, and Blood Borne Pathogen (BBP) safety protocols, • Familiarity with FDA / cGXP environments and associated compliance regulations, • Ability to plan, organize, prioritize and carry out work duties with minimum supervision. WATCH Where Service Matters: Job Posted by ApplicantPro

Job Description PURPOSE Ensure suitability of plasmapheresis donors, through the use of the SOP, current FDA and State guidelines, OSHA, CLIA, cGMP, and all internal company procedures. General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards. Must be Bi-Lingual in Spanish ESSENTIAL RESPONSIBILITIES & DUTIES • Perform History and Physical Exams on all applicant donors to assess donor suitability., • Perform Repeat History and Physical exams on an annual basis of qualified donors., • Explain process of Plasmapheresis., • Obtain signed consent for Plasmapheresis., • Explain all risk involved in Plasmapheresis., • Evaluate donor reactions and initiate appropriate therapy., • Initiate emergency medical procedures as needed, per standing orders of the physician., • Notify physician of all emergencies., • Serve as a liaison between the center and medical facilities and physician., • Review the donor’s accumulated lab data/test result and collection records as required to determine the donor’s continued suitability., • Provide appropriate and confidential counseling to ineligible donor candidates., • Counsel donors with positive test results and confirmed positive test results., • Maintain both donor and personnel confidentiality., • Review normal SPE test results., • Review and check donors with weight loss as needed., • Perform periodic checks of donor floor to observe donors during plasmapheresis process., • Function as a member of Quality Assurance team which monitors employee performance of screening and collection procedures., • Participate in employee safety, education and training programs., • Provide first aid for employee injuries., • Monitor emergency medical supplies on a monthly basis., • Must be trained at minimum in donor screening after 3 months from Physician Substitute certification., • Once certified, assist in reception area, donor floor and plasma processing as needed or directed by the center manager., • Assist with management and administration of employee counseling, testing and follow-up of employee exposures to plasma or blood., • Determine Hematocrit (HCT) and Protein (CA Centers RN only performs) via finger stick and use of the hematastat and refractometer., • Perform Proficiency Testing - (CA Centers RN only performs)., • Perform Statistical Analysis of Total Protein Results (CA Centers RN only performs)., • Perform daily controls., • Perform monthly statistical analysis., • Perform periodic Accu-Test (CA Centers RN only performs)., • Perform Calibration of machines as needed. Reporting and Accountability • Consult with Medical Director as necessary regarding donor suitability and treatment of donor reactions., • Consult with Medical Director as necessary regarding medications not listed in Medication Handbook., • Unusual medical problems, especially those involving donor selection and health, and both donor and employee safety, are to be brought to the attention of the Medical Director as soon as possible., • Duties and performance are subject to periodic review by Medical Director, QA Manager, and Corporate QA department., • Responsible for product safety by selecting only healthy donors, and for donor safety assuring that procedures are correctly performed., • Responsible for providing coverage for all the hours of operation that they are scheduled. This individual is responsible for finding an appropriate substitute if they cannot cover the hours., • Must read, understand and comply with all federal, state and local regulations. Other Responsibilities • Will make decisions regarding donor suitability, based on broad medical knowledge, familiarity with the current SOP and all applicable regulations to plasmapheresis., • Will evaluate donor reaction regarding type, severity, and appropriate treatment methods., • Consult with the medical director whenever an unusual problem occurs., • Will notify management if the center is operating outside of the standard operating procedures to prevent a detrimental impact on the donor, employees or product., • Will appraise new procedures and equipment for impact on donor, employee and product safety., • Provide oversight for Reception area., • Perform ancillary duties and act as a support person for the reception area, donor floor or plasma area., • Review SOP, cGMP regulations, and company policies on annual basis., • Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated., • Any other duties as assigned. REQUIREMENTS • Must be graduate of recognized educational program and be currently licensed in the state they are employed., • Physician Substitute – EMT: Must be EMT basic or above, • Physician Substitute – RN: Only RN’s or Licensed Physician Assistants may hold this position, • Physician Substitute – LVN/LPN: Licensed LVN or LPN, • Individual must meet and maintain current licensing requirement in the state they are employed and company with federal, state and local regulations., • Must maintain current certification in CPR, • Must complete our training program for Physician’s Substitute/Physician Assistant under the supervision of the Center’s Medical Director, and additional programs when deemed necessary, • Proficient with computer entry, • Minimum requirement is additionally certified in Donor Screening. Phlebotomy and Plasma Processing certification may be required by management, • May be required to travel for training, • Must be proficient in English (Read, Write, Speak)., • Bilingual -English/Spanish preferred PHYSICAL DEMANDS Performing the responsibilities of the job requires ability to talk and hear. Regularly required use hands and fingers, handle, or feel objects, tools or controls, and reach with the hands and arms. Frequently required to stand, for extended period of time (2–3-hour intervals), walk, climb or balance; and stoop, kneel, or crouch. Ability to read and type while sitting in front of a computer. Physically able to use and operate equipment used in assessing donor suitability as well as equipment used to harvest plasma. Manual dexterity to perform all phases of plasmapheresis. Ability to lift tug and pull up to 50 pounds. WORK ENVIRONMENT This job routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Occupational exposure to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as eyewear, lab coats, and gloves.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Description We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body requirements. Job Type: Full time Job Title: Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000/Yearly Responsibilities · Prepare and submit 510(k) applications for IVD products to ensure timely market entry. · Manage all aspects of regulatory submission processes, including documentation, timelines, and communication with regulatory bodies, as needed. · Conduct regulatory risk assessments and develop mitigation strategies for IVD products. · Stay updated with regulatory changes and ensure all IVD products comply with current regulations. · Liaise with internal departments (R&D, Quality, Manufacturing) to gather necessary documentation and data for regulatory submissions. · Provide regulatory guidance on product development projects to ensure compliance from concept to commercialization. · Review and provide input on product labeling, promotional materials, and change controls to ensure regulatory compliance. · Assist in the development and implementation of regulatory strategies and update stakeholders on regulatory developments affecting the company’s products. Requirements · Bachelor’s degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field. · Minimum of 5 years of experience in relevant industry with min or 3 year hands on experience in 510(k) preparations and submissions. · Strong understanding of FDA regulations, guidance documents, and processes related to IVD products. · Experience in interacting with regulatory agencies, particularly the FDA. · Excellent analytical, organizational, and communication skills. · Detail-oriented with the ability to manage multiple projects simultaneously. Preferred Skills RAC certification or similar. Benefits • Health Care Plan (Medical), • 401K, • Paid Time Off and Paid Sick Leave

Job DescriptionVTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that computerized systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and execution of validation protocols, risk assessments, and documentation to support the lifecycle of cGxP systems. RESPONSIBILITIES: • Authoring and Executing Software Test Protocols., • Draft, route, and execute Commissioning and Qualification Protocols (CQ, IQ, OQ, PQ) with Final Report., • Scheduling and execution of qualification activities, • Qualification data collection and analysis against acceptance criteria., • Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications., • Software Design Specification drafting and review., • Documentation generation and updates (SOPs, PFMEA, Forms, etc.), • Meeting attendance and project coordination., • Provide all services in accordance with FDA cGxP guidelines and regulations.QUALIFICATIONS:, • Bachelor's degree or higher in Engineering, Life Sciences, or related discipline., • 5+ years of relevant FDA-regulated industry experience., • Expertise in regulatory requirements and guidance, including 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5., • Familiarity with Python and Test Scripts., • 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation., • Must have experience working in an FDA-regulated environment., • Experience with Automation Equipment such as HMI's, Robotized Manufacturing Systems and Vision Sensors. Experience in manufacturing and testing of Medical Devices., • Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc., • Exceptional technical writing, review and analytical skills. VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence. As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. Powered by JazzHR OQZgGR6YKe

Job Description We are partnering with a client on the search for a Head of Biometrics to join their leadership team. Reporting to the Chief Medical Officer (CMO), the Head of Biometrics will provide leadership for driving the company's Biometrics activities for all studies across the world, including management of biostatistics, programming, medical writing, and data management. This leader will shape and influence the entire portfolio and will be responsible for creating vision, leading, developing, and implementing statistical solutions to optimally support all phases of clinical trial and project decision making. The ideal candidate will have proven leadership and communication skills with a drive for delivering innovative bioinformatics-based analysis solutions across a broad range of use cases. This role requires someone with a track record of establishing a strategic roadmap for innovations across bioinformatic methods and algorithms, delivering continuous improvements in core analysis capabilities, establishing an information delivering system, and effectively working with stakeholders. Key Job Responsibilities * Provide leadership and vision for the Biometrics team; responsible for setting, designing, and developing the vision and goals for Biostatistics, Statistical Programming, Data Management, and Medical Writing. Translate strategies and tactical plans into practical and effective actions. * Manage the development of SOPs, statistical programs, and deliverables by CROs for biostatistics, statistical programming, and data management. Collaborate with other functions to ensure data collection and reporting is done in conformance with ongoing practices and regulatory expectations. * Deliver statistically sound scientific methodology experimental design and data analysis input to meet project objectives for global regulatory organizations such as FDA and EMA. Adheres to regulatory guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development. * Author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents, and scientific publications; generates or reviews study randomization and sample size/power estimations. * Liaison for all statistical and operational aspects pertaining to Data Monitoring Committees. * Reports study results of appropriate statistical analyses, in collaboration with clinical development, to provide appropriate interpretation of data and sound study conclusions. * Becomes familiar with the disease states and therapeutic space to enhance the level of collaboration and be able to evaluate implications of study designs. Leadership Attributes * Able to thrive in a fast-paced, dynamic small company environment with ability to adjust workload based upon changing priorities. * Critical thinker with a demonstrated ability to collaborate with both leadership and teams, demonstrating ability to influence, make sound decisions, and drive alignment. * Natural leader with a positive management style, combined with superior communication skills and unwavering ethics and integrity. * Proven interpersonal skills and executive presence, with an effective ability to quickly establish credibility, trust, and support within all levels of the organization. * Leads and reinforces company values and culture in day-to-day behaviors, management style, and expectations. * Self-starter, able to drive work forward within an agile environment with a track record of executing against results. Requirements * A minimum of 15 years of progressive, relevant leadership experience in pharmaceutical or biotechnology clinical trials. Must have early development experience while full-cycle drug development/pharmaceutical experience is highly preferred. * An advanced degree MS or PhD in Statistics, or Biostatistics, or a related field. * Technical knowledge of database structure, and relevant statistical software (e.g., SAS®, East®, and R. programming) background preferable. * Experience with statistical and operational aspects pertaining to Data Monitoring Committees. * Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion. * Able to understand and communicate scientific data effectively at all levels and present complex and/or new ideas with clarity and simplicity. Experienced presentation skills tailored to engage and communicate with diverse audiences (investigator meetings, site personnel, KOL interactions and internal project teams).

Job Description PURPOSE Responsible for conducting a series of screening procedures to determine suitability for plasma donation. Screening procedures may include reviewing health-related documents and taking vital signs including blood pressure, pulse, and temperature. General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards. ESSENTIAL RESPONSIBILITIES & DUTIES • Administer health history questionnaire to new and repeat donors, as applicable, • Manage donor flow throughout the center, • Communicate delays and other issues to center management, nurse, and/or other necessary parties, • Document activities when necessary, • Set up and operate instruments used for the testing of donor vitals and other station equipment, • Assess donor weight and vital records, • Ensure the area is clean and maintained according to regulations, • Refill supplies and clean machines/station at the conclusion of the shift, • Answer donor inquiries, • Adhere to all company policies, procedures, and safety rules as stated in the Employee Handbook and as otherwise posted or communicated., • Any other duties as assigned. REQUIREMENTS • High school diploma or equivalent (Must be able to show proof), • Strong customer service skills., • Must be proficient in English (Read, Write, Speak) with legible handwriting, • Current CPR card, • Proficient with computer entry, • May be required to travel for training, • Bilingual (English/Spanish) PHYSICAL DEMANDS Performing the responsibilities of the job requires the ability to talk and hear. Regularly required to use hands and fingers, to handle & feel objects, tools, and controls; reach with hands and arms. Vision abilities required by this job include close vision. Required to stand for extended intervals, walk, climb and balance; stoop, kneel and crouch. Physical ability to operate equipment used in screening and donor floor areas that may require repetitive motions and manual dexterity. Ability to lift, tug, and pull up to 50 pounds. Ability to read while standing or sitting in front of a computer for short periods of time. WORK ENVIRONMENT This job routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Occupational exposure to bloodborne pathogens and other conditions are common to a donor center. Personal protective equipment required such as eyewear, lab coats, and gloves.

Job Description About Tr1X Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit . Position Summary The Associate Director, Clinical Quality (ADCQ) is a key member of the Quality team ensuring the Tr1X clinical practices meet the highest standards of quality, compliance, and continuous improvement and aligned with industry standards and all applicable regulations (local, state, FDA, and other relevant agencies). The ADCQ reports to the Executive Director, Quality and is responsible for all aspects of Clinical Quality. The ADCQ leads GCP compliance strategies and is an integral part of all clinical program teams. The ADCQ works with both internal and external stakeholders to meet timelines and internal deliverables and is a partner with the clinical program teams to ensure regulatory compliance is achieved. The person in the ADCQ role is someone who has broad and diverse knowledge of clinical quality in support of clinical program objectives. The responsibilities of this position require the ADCQ to be highly collaborative and possess advanced interpersonal and influencing skills. Key Responsibilities • Oversee all aspects of Clinical Quality for internal and external processes, including CROs, vendors, and investigator sites., • Review internal and external documentation to ensure quality, regulatory compliance and audit-readiness., • Document internal regulatory processes and evaluate quality events, incidents, queries, and complaints., • Utilize guidance regulatory documents, international standards, and industry standards and interpret and apply to clinical trials and activities., • Conduct audits of clinical documentation, investigator sites, vendors, systems., • Lead root cause analyses and implement corrective and preventive action plans., • Collaborate with internal and external stakeholders to align quality strategies with organizational goals., • Assume a lead role in representing clinical quality at internal meetings and in preparing and drafting clinical quality policies, procedures, regulatory submissions and GCP training., • Communicate any critical compliance risks to senior management and recommend possible solutions., • Assist in the development of documentation and implementation of systems and SOPs., • Support all Quality team needs as identified by management., • Keep abreast of and make recommendations to management on new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc., • Bachelor's degree in a scientific discipline or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained., • Minimum 8 years of related experience with a minimum 5 years of experience in clinical quality management in the pharmaceutical or biotech industry., • Experience and knowledge in the establishment and management of quality systems, vendor and investigator site audits, and CRO oversight., • Working knowledge and adherence to FDA, ISO and ICH regulatory guidance and regulations, clinical quality operations, and CTD/eCTD standards., • Exceptional interpersonal skills with the ability to effectively develop supportive and collaborative relationships., • Superior organizational, communication, and problem-solving skills., • Experience with cell therapy products and prior participation in regulatory inspections desirable., • Legally authorized to work for any employer in the U.S., • Periodic travel is required to CROs and vendor sites. Working at Tr1X At Tr1X, our team is united by a singular shared mission: to transform patients' lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured. Base Pay Range Anticipated: $175,000 - $200,000 Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position. Compensation and Benefits Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays. Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at . Notice to Employment Agencies The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Senior Regulatory Affairs Manager Location: Onsite - Atlanta, or San Diego Position Summary: The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices. Key Responsibilities: • Prepare, review, and submit regulatory documents to FDA., • Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals., • Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards., • Provide regulatory guidance to R&D team during product development life cycle., • Stay updated on changes in regulatory requirements and communicate potential impacts to the organization., • Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways., • Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines., • Represent the company in meetings with regulatory agencies and external partners as needed., • Master’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred., • Minimum of 7-10 years of experience in regulatory affairs within the medical device industry., • Proven track record of leading and successfully obtaining 510(k) and De Novo clearances/approvals., • Experience in interacting with FDA and other regulatory agencies. Skills & Competencies: • In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations., • Strong leadership and project management skills, with the ability to manage multiple projects and priorities., • Excellent communication, negotiation, and problem-solving skills., • Ability to work collaboratively in a cross-functional team environment., • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Senior Customer Support Specialist. S/he maintains direct contact with customers before and/or after the sale. S/he develops and maintains positive customer relations with clients/customers, which can substantially affect service and/or product revenue(s). Core Responsibilities Include: • Receives and responds to customer calls; provides answers to basic inquiries such as products sold, shipping dates, back orders, pricing and availability. Receives and responds to customer calls for LabPMM providing answers to inquiries such as test results and test look up., • Directs the customer to the employee most appropriate to answer their inquiry, such as technical support for product performance questions., • Escalates satisfaction issues as appropriate., • Accepts and processes orders received via mail, email, phone, or fax in a timely manner. Accurately processes and correctly verifies orders., • Performs data entry and special handling of high-level account orders into the ERP database system, checking product information, availability, and the status of the shipments., • Ensures product delivery in accordance with customer requirements and manufacturing capabilities. Investigates problems related to shipment of products, credits and new orders., • Closely tracks status of orders & shipments, such as monitoring account set up, coordinate with site (sponsor, CRO) any required documentation for shipments, etc., closely monitors the status of outbound shipments., • Prepares shipping documentation for international shipments, which do not use FedEx as the shipping carrier and ensures that these shipments are shipped in accordance with controlled procedures and product requirements. Ensures international shipments meet all the export requirements and procedures, including electronic submission of EEI via AES shipment with commercial invoices., • Assists in generating quotes requested by Customers and Account Managers., • Distributes literature/materials in response to inquiries, as necessary., • Performs tracking of various spreadsheets for quality and performance improvement., • Assists in creating and implementing process documents., • Assists in training newly hired team members., • High School Diploma and, typically, 4+ year(s) of applicable experience in a life science FDA regulated industry. A.S. degree or equivalent college coursework, trade school and/or applicable certification is advantageous. Equivalent combination of education and experience will be considered., • A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options., • A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day., • A positive workplace culture with an emphasis on support, respect and belonging., • A diverse and inclusive work environment where you will learn, grow, and make new friends., • Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits. Invivoscribe is an Equal Opportunity Employer.